Trial Outcomes & Findings for Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers (NCT NCT02478463)
NCT ID: NCT02478463
Last Updated: 2020-06-22
Results Overview
Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.
COMPLETED
PHASE1
19 participants
Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose
2020-06-22
Participant Flow
This was a Phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir (CAB) long-acting (LA) in the blood plasma and anatomical tissues and secretions associated with sexual human immunodeficiency virus (HIV)-1 transmission. The study was conducted across two centers in the United States.
A total of 29 participants were screened, of which 10 failed screening. A total of 19 participants were enrolled in the study and received study treatment.
Participant milestones
| Measure |
Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg
Participants received once daily oral dose of 30 milligram (mg) cabotegravir for 28 days during the oral lead-in phase in Period 1 followed by a single intramuscular (IM) dose of 600 mg cabotegravir in Period 2. There was a washout period of up to 42 days between the two treatment periods.
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|---|---|
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Treatment Period 1 (Up to Day 29)
STARTED
|
19
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|
Treatment Period 1 (Up to Day 29)
COMPLETED
|
18
|
|
Treatment Period 1 (Up to Day 29)
NOT COMPLETED
|
1
|
|
Washout Period (Up to 42 Days)
STARTED
|
18
|
|
Washout Period (Up to 42 Days)
COMPLETED
|
17
|
|
Washout Period (Up to 42 Days)
NOT COMPLETED
|
1
|
|
Treatment Period 2 (Up to 52 Weeks)
STARTED
|
17
|
|
Treatment Period 2 (Up to 52 Weeks)
COMPLETED
|
16
|
|
Treatment Period 2 (Up to 52 Weeks)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg
Participants received once daily oral dose of 30 milligram (mg) cabotegravir for 28 days during the oral lead-in phase in Period 1 followed by a single intramuscular (IM) dose of 600 mg cabotegravir in Period 2. There was a washout period of up to 42 days between the two treatment periods.
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|---|---|
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Treatment Period 1 (Up to Day 29)
Physician Decision
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1
|
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Washout Period (Up to 42 Days)
Lost to Follow-up
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1
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Treatment Period 2 (Up to 52 Weeks)
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg
n=19 Participants
Participants received once daily oral dose of 30 milligram (mg) cabotegravir for 28 days during the oral lead-in phase in Period 1 followed by a single intramuscular (IM) dose of 600 mg cabotegravir in Period 2. There was a washout period of up to 42 days between the two treatment periods.
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|---|---|
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Age, Continuous
|
33.3 Years
STANDARD_DEVIATION 9.12 • n=99 Participants
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|
Sex: Female, Male
Female
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10 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
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12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=15 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 4, n=15
|
2.5583 Micrograms per milliliter
Standard Deviation 1.00963
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 52, n=14
|
0.0089 Micrograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.
|
|
Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 1: Pre-dose, n=15
|
0.0000 Micrograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 1: 4 hours, n=15
|
0.2864 Micrograms per milliliter
Standard Deviation 0.10463
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 3, n=15
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3.2748 Micrograms per milliliter
Standard Deviation 1.74419
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|
Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 5, n=15
|
5.1071 Micrograms per milliliter
Standard Deviation 3.09180
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 8, n=15
|
5.0433 Micrograms per milliliter
Standard Deviation 2.92704
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 8, n=15
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0.9683 Micrograms per milliliter
Standard Deviation 0.73601
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 12, n=15
|
0.3925 Micrograms per milliliter
Standard Deviation 0.40471
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 24, n=15
|
0.0550 Micrograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.
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Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 36, n=15
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0.0213 Micrograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.
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PRIMARY outcome
Timeframe: One sample on Day 3 and Week 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Vaginal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM) comprised of all participants who underwent sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and have both evaluable PK and evaluable tissues-fluid parameters estimated in vaginal tissue/cervical tissue/cervicovaginal fluid/rectal tissue/rectal fluid.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants)
Day 3
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0.5286 Micrograms per milliliter
Standard Deviation 0.48215
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Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants)
Week 8
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0.1809 Micrograms per milliliter
Standard Deviation 0.14606
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PRIMARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)
Day 3
|
0.8016 Micrograms per milliliter
Standard Deviation 0.70126
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Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)
Day 8
|
0.9261 Micrograms per milliliter
Standard Deviation 0.85513
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Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)
Week 4
|
0.4409 Micrograms per milliliter
Standard Deviation 0.29216
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Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)
Week 8
|
0.1570 Micrograms per milliliter
Standard Deviation 0.14909
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Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)
Week 12
|
0.0460 Micrograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.
|
PRIMARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Day 3
|
0.6604 Micrograms per milliliter
Standard Deviation 0.91588
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Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Day 8
|
0.6175 Micrograms per milliliter
Standard Deviation 0.59792
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Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 4
|
0.3209 Micrograms per milliliter
Standard Deviation 0.37093
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Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 8
|
0.0905 Micrograms per milliliter
Standard Deviation 0.14821
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Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 12
|
0.0901 Micrograms per milliliter
Standard Deviation 0.18306
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PRIMARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=13 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Cabotegravir Concentration in Rectal Tissue Following IM Administration
Week 12
|
0.0348 Micrograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.
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|
Cabotegravir Concentration in Rectal Tissue Following IM Administration
Day 3
|
0.2824 Micrograms per milliliter
Standard Deviation 0.17814
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Cabotegravir Concentration in Rectal Tissue Following IM Administration
Day 8
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0.5146 Micrograms per milliliter
Standard Deviation 0.26514
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Cabotegravir Concentration in Rectal Tissue Following IM Administration
Week 4
|
0.2620 Micrograms per milliliter
Standard Deviation 0.10476
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Cabotegravir Concentration in Rectal Tissue Following IM Administration
Week 8
|
0.1037 Micrograms per milliliter
Standard Deviation 0.10050
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PRIMARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Cabotegravir Concentration in Rectal Fluid Following IM Administration
Day 3
|
1.3868 Micrograms per milliliter
Standard Deviation 1.88097
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Cabotegravir Concentration in Rectal Fluid Following IM Administration
Week 4
|
5.2674 Micrograms per milliliter
Standard Deviation 7.99949
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Cabotegravir Concentration in Rectal Fluid Following IM Administration
Day 8
|
3.2046 Micrograms per milliliter
Standard Deviation 2.68417
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Cabotegravir Concentration in Rectal Fluid Following IM Administration
Week 8
|
0.3233 Micrograms per milliliter
Standard Deviation 0.22764
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Cabotegravir Concentration in Rectal Fluid Following IM Administration
Week 12
|
0.7901 Micrograms per milliliter
Standard Deviation 1.75430
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SECONDARY outcome
Timeframe: One sample on Day 3 and Week 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Vaginal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
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|---|---|
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Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Day 3
|
0.128 Ratio
Geometric Coefficient of Variation 43.38
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|
Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 8
|
0.199 Ratio
Geometric Coefficient of Variation 32.66
|
SECONDARY outcome
Timeframe: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervical tissue to cabotegravir concentration in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
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Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Day 3
|
0.203 Ratio
Geometric Coefficient of Variation 36.14
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|
Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Day 8
|
0.174 Ratio
Geometric Coefficient of Variation 44.85
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Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 4
|
0.139 Ratio
Geometric Coefficient of Variation 99.93
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Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 8
|
0.139 Ratio
Geometric Coefficient of Variation 59.16
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Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 12
|
0.101 Ratio
Geometric Coefficient of Variation 45.10
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SECONDARY outcome
Timeframe: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervicovaginal fluid to cabotegravir concentration in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 4
|
0.073 Ratio
Geometric Coefficient of Variation 277.59
|
|
Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 8
|
0.057 Ratio
Geometric Coefficient of Variation 101.03
|
|
Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Week 12
|
0.082 Ratio
Geometric Coefficient of Variation 112.91
|
|
Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Day 3
|
0.116 Ratio
Geometric Coefficient of Variation 174.76
|
|
Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)
Day 8
|
0.124 Ratio
Geometric Coefficient of Variation 73.53
|
SECONDARY outcome
Timeframe: One sample on Day 3, 8, Weeks 4, 8 and 12Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and cervicovaginal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervical tissue to cabotegravir concentration in cervicovaginal fluid is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 12
|
1.195 Ratio
Geometric Coefficient of Variation 105.01
|
|
Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Day 3
|
1.738 Ratio
Geometric Coefficient of Variation 118.75
|
|
Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Day 8
|
1.405 Ratio
Geometric Coefficient of Variation 81.10
|
|
Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 4
|
1.883 Ratio
Geometric Coefficient of Variation 172.44
|
|
Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 8
|
2.785 Ratio
Geometric Coefficient of Variation 110.92
|
SECONDARY outcome
Timeframe: One sample on Day 3 and Week 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Vaginal tissue and cervicovaginal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in cervicovaginal fluid is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Day 3
|
1.095 Ratio
Geometric Coefficient of Variation 233.20
|
|
Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)
Week 8
|
3.613 Ratio
Geometric Coefficient of Variation 115.25
|
SECONDARY outcome
Timeframe: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal tissue to cabotegravir concentration in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=13 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 3
|
0.078 Ratio
Geometric Coefficient of Variation 43.13
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 8
|
0.105 Ratio
Geometric Coefficient of Variation 22.92
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 4
|
0.104 Ratio
Geometric Coefficient of Variation 18.79
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 8
|
0.096 Ratio
Geometric Coefficient of Variation 27.81
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 12
|
0.091 Ratio
Geometric Coefficient of Variation 38.62
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal fluid to cabotegravir concentration in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 3
|
0.286 Ratio
Geometric Coefficient of Variation 157.60
|
|
Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration
Day 8
|
0.581 Ratio
Geometric Coefficient of Variation 140.37
|
|
Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 4
|
0.460 Ratio
Geometric Coefficient of Variation 923.37
|
|
Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 8
|
0.302 Ratio
Geometric Coefficient of Variation 140.54
|
|
Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration
Week 12
|
0.514 Ratio
Geometric Coefficient of Variation 185.97
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Rectal tissue and rectal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal tissue to cabotegravir concentration in rectal fluid is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration
Day 3, n=11
|
0.271 Ratio
Geometric Coefficient of Variation 150.25
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration
Day 8, n=12
|
0.185 Ratio
Geometric Coefficient of Variation 140.92
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration
Week 4, n=12
|
0.230 Ratio
Geometric Coefficient of Variation 1082.13
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration
Week 8, n=12
|
0.366 Ratio
Geometric Coefficient of Variation 133.20
|
|
Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration
Week 12, n=12
|
0.093 Ratio
Geometric Coefficient of Variation 294.16
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=15 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Maximum Observed Concentration (Cmax) of Cabotegravir in Blood Plasma Following IM Administration
|
5.04 Micrograms per milliliter
Geometric Coefficient of Variation 62.0
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cmax of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
0.81 Micrograms per milliliter
Geometric Coefficient of Variation 105.0
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cmax of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
0.55 Micrograms per milliliter
Geometric Coefficient of Variation 118.3
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=13 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cmax of Cabotegravir in Rectal Tissue Following IM Administration
|
0.50 Micrograms per milliliter
Geometric Coefficient of Variation 47.0
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cmax of Cabotegravir in Rectal Fluid Following IM Administration
|
3.27 Micrograms per milliliter
Geometric Coefficient of Variation 171.9
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, One sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=15 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC[0-last]) for Cabotegravir in Blood Plasma Following IM Administration
|
3992.25 Hours*microgram per milliliter
Geometric Coefficient of Variation 24.5
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-last) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
522.73 Hours*microgram per milliliter
Geometric Coefficient of Variation 77.0
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-last) of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
324.33 Hours*microgram per milliliter
Geometric Coefficient of Variation 121.4
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=13 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-last) for Cabotegravir in Rectal Tissue Following IM Administration
|
347.73 Hours*microgram per milliliter
Geometric Coefficient of Variation 35.5
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-last) for Cabotegravir in Rectal Fluid Following IM Administration
|
1841.23 Hours*microgram per milliliter
Geometric Coefficient of Variation 193.8
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=14 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-inf]) for Cabotegravir in Blood Plasma Following IM Administration
|
4172.17 Hours*microgram per milliliter
Geometric Coefficient of Variation 23.9
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=1 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-inf) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
695.72 Hours*microgram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-inf) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
399.07 Hours*microgram per milliliter
Geometric Coefficient of Variation 99.9
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=3 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-inf) for Cabotegravir in Rectal Tissue Following IM Administration
|
291.98 Hours*microgram per milliliter
Geometric Coefficient of Variation 34.6
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=2 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-inf) for Cabotegravir in Rectal Fluid Following IM Administration
|
850.05 Hours*microgram per milliliter
Geometric Coefficient of Variation 42.7
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8 and Week 4 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=15 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Week (WK) 4 (AUC[0-WK4]) for Cabotegravir in Blood Plasma Following IM Administration
|
2141.91 Hours*microgram per milliliter
Geometric Coefficient of Variation 59.2
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=6 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK4) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
277.48 Hours*microgram per milliliter
Geometric Coefficient of Variation 103.6
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK4) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
203.32 Hours*microgram per milliliter
Geometric Coefficient of Variation 125.5
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK4) for Cabotegravir in Rectal Tissue Following IM Administration
|
206.28 Hours*microgram per milliliter
Geometric Coefficient of Variation 57.2
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK4) for Cabotegravir in Rectal Fluid Following IM Administration
|
1170.49 Hours*microgram per milliliter
Geometric Coefficient of Variation 192.1
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4 and 8 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=15 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Week 8 (AUC[0-WK8]) for Cabotegravir in Blood Plasma Following IM Administration
|
3213.62 Hours*microgram per milliliter
Geometric Coefficient of Variation 40.1
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK8) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
364.74 Hours*microgram per milliliter
Geometric Coefficient of Variation 85.2
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK8) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
281.60 Hours*microgram per milliliter
Geometric Coefficient of Variation 124.8
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK8) for Cabotegravir in Rectal Tissue Following IM Administration
|
287.35 Hours*microgram per milliliter
Geometric Coefficient of Variation 38.7
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK8) for Cabotegravir in Rectal Fluid Following IM Administration
|
1575.54 Hours*microgram per milliliter
Geometric Coefficient of Variation 202.9
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=14 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Week 12 (AUC[0-WK12]) for Cabotegravir in Blood Plasma Following IM Administration
|
3639.01 Hours*microgram per milliliter
Geometric Coefficient of Variation 35.6
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=3 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK12) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
349.98 Hours*microgram per milliliter
Geometric Coefficient of Variation 78.9
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK12) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
380.92 Hours*microgram per milliliter
Geometric Coefficient of Variation 107.8
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK12) for Cabotegravir in Rectal Tissue Following IM Administration
|
323.91 Hours*microgram per milliliter
Geometric Coefficient of Variation 54.8
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
AUC(0-WK12) for Cabotegravir in Rectal Fluid Following IM Administration
|
1345.13 Hours*microgram per milliliter
Geometric Coefficient of Variation 137.7
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dosePopulation: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=14 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Apparent Terminal Phase Half-life (t1/2) of Cabotegravir in Blood Plasma Following IM Administration
|
459.53 Hours
Geometric Coefficient of Variation 81.4
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=1 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
t1/2 of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)
|
363.41 Hours
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
t1/2 of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)
|
355.83 Hours
Geometric Coefficient of Variation 79.4
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=3 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
t1/2 of Cabotegravir in Rectal Tissue Following IM Administration
|
567.48 Hours
Geometric Coefficient of Variation 23.3
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=2 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
t1/2 of Cabotegravir in Rectal Fluid Following IM Administration
|
306.58 Hours
Geometric Coefficient of Variation 3.5
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in cervical tissue to AUC(0-last) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-last) in Cervical Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.1215 Ratio
Geometric Coefficient of Variation 64.86
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in rectal tissue to AUC(0-last) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=13 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-last) in Rectal Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration
|
0.0849 Ratio
Geometric Coefficient of Variation 21.13
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in cervical tissue to AUC(0-inf) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=1 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-inf) in Cervical Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.1943 Ratio
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in rectal tissue to AUC(0-inf) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=3 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-inf) in Rectal Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration
|
0.0766 Ratio
Geometric Coefficient of Variation 42.26
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in cervical tissue to AUC(0-WK4) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=6 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-Wk4) in Cervical Tissue to AUC(0-Wk4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.1553 Ratio
Geometric Coefficient of Variation 50.33
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in rectal tissue to AUC(0-WK4) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-Wk 4) in Rectal Tissue to AUC(0-Wk 4) in Blood Plasma for Cabotegravir Following IM Administration
|
0.1000 Ratio
Geometric Coefficient of Variation 19.30
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in cervical tissue to AUC(0-WK8) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK8) in Cervical Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.1492 Ratio
Geometric Coefficient of Variation 52.30
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in rectal tissue to AUC(0-WK8) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK8) in Rectal Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration
|
0.1062 Ratio
Geometric Coefficient of Variation 17.46
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in cervical tissue to AUC(0-WK12) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=3 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK12) in Cervical Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.1230 Ratio
Geometric Coefficient of Variation 48.22
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in rectal tissue to AUC(0-WK12) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK12) in Rectal Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration
|
0.1089 Ratio
Geometric Coefficient of Variation 13.50
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in cervicovaginal fluid to AUC(0-last) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-last) in Cervicovaginal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration-female Participants
|
0.0754 Ratio
Geometric Coefficient of Variation 99.37
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in rectal fluid to AUC(0-last) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-last) in Rectal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration
|
0.4445 Ratio
Geometric Coefficient of Variation 204.26
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in cervicovaginal fluid to AUC(0-inf) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-inf) in Cervicovaginal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.0857 Ratio
Geometric Coefficient of Variation 99.10
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in rectal fluid to AUC(0-inf) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=2 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-inf) in Rectal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration
|
0.1949 Ratio
Geometric Coefficient of Variation 80.06
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in cervicovaginal fluid to AUC(0-WK4) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK4) in Cervicovaginal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.1032 Ratio
Geometric Coefficient of Variation 119.71
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8 and Week 4 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in rectal fluid to AUC(0-WK4) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK4) in Rectal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration
|
0.5452 Ratio
Geometric Coefficient of Variation 223.58
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in cervicovaginal fluid to AUC(0-WK8) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK8) in Cervicovaginal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.0925 Ratio
Geometric Coefficient of Variation 124.99
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4 and 8 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in rectal fluid to AUC(0-WK8) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK8) in Rectal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration
|
0.4845 Ratio
Geometric Coefficient of Variation 212.20
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in cervicovaginal fluid to AUC(0-WK12) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=4 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK12) in Cervicovaginal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)
|
0.0867 Ratio
Geometric Coefficient of Variation 99.56
|
SECONDARY outcome
Timeframe: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dosePopulation: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in rectal fluid to AUC(0-WK12) in blood plasma is presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Ratio of AUC(0-WK12) in Rectal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration
|
0.3863 Ratio
Geometric Coefficient of Variation 154.56
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 28Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Vaginal tissue samples were collected to measure cabotegravir concentration in vaginal tissue following oral 30 mg dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cabotegravir Concentration in Vaginal Tissue Following Oral Administration (Female Participants)
|
0.7477 Micrograms per milliliter
Standard Deviation 0.50171
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 28Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervical tissue samples were collected to measure cabotegravir concentration in cervical tissue following oral 30 mg dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cabotegravir Concentration in Cervical Tissue Following Oral Administration (Female Participants)
|
1.1009 Micrograms per milliliter
Standard Deviation 0.53987
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 28Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Cervicovaginal fluid samples were collected to measure cabotegravir concentration in cervicovaginal fluid following oral 30 mg dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=7 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cabotegravir Concentration in Cervicovaginal Fluid Following Oral Administration (Female Participants)
|
0.8959 Micrograms per milliliter
Standard Deviation 0.95662
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 28Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal tissue samples were collected to measure cabotegravir concentration in rectal tissue following oral 30 mg dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=13 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cabotegravir Concentration in Rectal Tissue Following Oral Administration
|
0.6104 Micrograms per milliliter
Standard Deviation 0.24854
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 28Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
Rectal fluid samples were collected to measure cabotegravir concentration in rectal fluid following oral 30 mg dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=12 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cabotegravir Concentration in Rectal Fluid Following Oral Administration
|
5.5457 Micrograms per milliliter
Standard Deviation 6.41639
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 28Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure cabotegravir concentration in blood plasma following oral 30 mg dose at indicated time-points.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=15 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Cabotegravir Concentration in Blood Plasma Following Oral Administration
|
5.7313 Micrograms per milliliter
Standard Deviation 2.08899
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Safety Population comprised of all participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment, associated with liver injury and impaired liver function was categorized as SAE. Number of participants with any non-SAE and SAE are presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=19 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir
Any Non-SAE
|
10 Participants
|
|
Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir
Any SAE
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment, associated with liver injury and impaired liver function was categorized as SAE. Number of participants with any non-SAE and SAE are presented.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir
Any Non-SAE
|
17 Participants
|
|
Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir
Any SAE
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters; ALT, ALP and AST following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)
AST, Day 14
|
-0.3 International units per Liter
Standard Deviation 3.60
|
|
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)
ALT, Day 14
|
1.7 International units per Liter
Standard Deviation 8.98
|
|
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)
ALT, Day 29
|
3.5 International units per Liter
Standard Deviation 10.12
|
|
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)
ALP, Day 14
|
-0.2 International units per Liter
Standard Deviation 6.44
|
|
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)
ALP, Day 29
|
-0.4 International units per Liter
Standard Deviation 3.24
|
|
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)
AST, Day 29
|
1.1 International units per Liter
Standard Deviation 6.14
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of clinical chemistry parameters; ALT, ALP and AST following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
AST, Week 12, n=16
|
-0.1 International units per Liter
Standard Deviation 3.50
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
ALT, Week 4, n=17
|
-0.2 International units per Liter
Standard Deviation 4.05
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
ALT, Week 8, n=16
|
-0.8 International units per Liter
Standard Deviation 5.33
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
ALT, Week 12, n=16
|
-1.4 International units per Liter
Standard Deviation 3.81
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
ALP, Week 4, n=15
|
2.1 International units per Liter
Standard Deviation 6.39
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
ALP, Week 8, n=16
|
0.6 International units per Liter
Standard Deviation 8.43
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
ALP, Week 12, n=16
|
1.3 International units per Liter
Standard Deviation 6.57
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
AST, Week 4, n=17
|
0.1 International units per Liter
Standard Deviation 2.87
|
|
Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)
AST, Week 8, n=16
|
0.1 International units per Liter
Standard Deviation 3.76
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter; creatine kinase following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose)
Day 14
|
-19.9 International units per Liter
Standard Deviation 27.23
|
|
Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose)
Day 29
|
-8.9 International units per Liter
Standard Deviation 46.56
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter; creatine kinase following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=16 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose)
Week 12
|
22.2 International units per Liter
Standard Deviation 92.09
|
|
Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose)
Week 8
|
19.6 International units per Liter
Standard Deviation 67.42
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of clinical chemistry parameters; creatinine, direct bilirubin and total bilirubin following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)
Creatinine, Day 14, n=18
|
0.491 Micromoles per liter
Standard Deviation 5.6500
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)
Creatinine, Day 29, n=18
|
-0.491 Micromoles per liter
Standard Deviation 7.0929
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)
Direct bilirubin, Day 14, n=11
|
-0.311 Micromoles per liter
Standard Deviation 0.6917
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)
Direct bilirubin, Day 29, n=12
|
0.428 Micromoles per liter
Standard Deviation 0.7734
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)
Total bilirubin, Day 14, n=16
|
-1.282 Micromoles per liter
Standard Deviation 1.9245
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)
Total bilirubin, Day 29, n=16
|
0.000 Micromoles per liter
Standard Deviation 2.7217
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of clinical chemistry parameters; creatinine, direct bilirubin and total bilirubin following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Creatinine, Week 12, n=16
|
-3.315 Micromoles per liter
Standard Deviation 8.4637
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Total bilirubin, Week 12, n=14
|
1.099 Micromoles per liter
Standard Deviation 4.5789
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Creatinine, Week 4, n=17
|
-3.640 Micromoles per liter
Standard Deviation 8.3037
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Creatinine, Week 8, n=16
|
-5.525 Micromoles per liter
Standard Deviation 5.4732
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Direct bilirubin, Week 4, n=10
|
-0.171 Micromoles per liter
Standard Deviation 0.5407
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Direct bilirubin, Week 8, n=10
|
0.171 Micromoles per liter
Standard Deviation 1.2617
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Direct bilirubin, Week 12, n=9
|
0.190 Micromoles per liter
Standard Deviation 1.3368
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Total bilirubin, Week 4, n=16
|
0.641 Micromoles per liter
Standard Deviation 3.1142
|
|
Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)
Total bilirubin, Week 8, n=15
|
0.114 Micromoles per liter
Standard Deviation 4.2118
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters; albumin and total protein following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose)
Albumin, Day 14
|
-0.6 Grams per liter
Standard Deviation 2.85
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose)
Albumin, Day 29
|
-0.3 Grams per liter
Standard Deviation 1.53
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose)
Total protein, Day 14
|
-1.7 Grams per liter
Standard Deviation 3.48
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose)
Total protein, Day 29
|
-1.4 Grams per liter
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of clinical chemistry parameters; albumin and total protein following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)
Total protein, Week 8, n=15
|
-0.1 Grams per liter
Standard Deviation 3.53
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)
Total protein, Week 12, n=16
|
0.5 Grams per liter
Standard Deviation 4.31
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)
Albumin, Week 4, n=17
|
0.3 Grams per liter
Standard Deviation 2.66
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)
Albumin, Week 8, n=16
|
0.3 Grams per liter
Standard Deviation 2.41
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)
Albumin, Week 12, n=16
|
0.6 Grams per liter
Standard Deviation 2.42
|
|
Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)
Total protein, Week 4, n=17
|
0.2 Grams per liter
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters; calcium, glucose, potassium, sodium and urea enzymatic colorimetry (UEC) following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Glucose, Day 29
|
0.672288 Millimoles per Liter
Standard Deviation 1.0302415
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Calcium, Day 14
|
-0.027722 Millimoles per Liter
Standard Deviation 0.0905221
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Calcium, Day 29
|
-0.033267 Millimoles per Liter
Standard Deviation 0.0774940
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Glucose, Day 14
|
0.391654 Millimoles per Liter
Standard Deviation 0.6929202
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Potassium, Day 14
|
-0.05 Millimoles per Liter
Standard Deviation 0.296
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Potassium, Day 29
|
-0.04 Millimoles per Liter
Standard Deviation 0.241
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Sodium, Day 14
|
-0.9 Millimoles per Liter
Standard Deviation 1.53
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
Sodium, Day 29
|
-0.3 Millimoles per Liter
Standard Deviation 2.43
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
UEC, Day 14
|
-0.2975 Millimoles per Liter
Standard Deviation 0.97384
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)
UEC, Day 29
|
-0.2578 Millimoles per Liter
Standard Deviation 1.14741
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of clinical chemistry parameters; calcium, glucose, potassium, sodium and UEC following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Calcium, Week 4, n=17
|
-0.002935 Millimoles per Liter
Standard Deviation 0.0763335
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Glucose, Week 8, n=16
|
-0.003469 Millimoles per Liter
Standard Deviation 0.8073398
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Sodium, Week 8, n=16
|
0.1 Millimoles per Liter
Standard Deviation 1.77
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Sodium, Week 12, n=16
|
-0.6 Millimoles per Liter
Standard Deviation 1.79
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Calcium, Week 8, n=15
|
-0.003327 Millimoles per Liter
Standard Deviation 0.0610177
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Calcium, Week 12, n=16
|
-0.001559 Millimoles per Liter
Standard Deviation 0.0666177
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Glucose, Week 4, n=17
|
-0.111020 Millimoles per Liter
Standard Deviation 0.6467570
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Glucose, Week 12, n=16
|
-0.149183 Millimoles per Liter
Standard Deviation 0.6402427
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Potassium, Week 4, n=17
|
-0.08 Millimoles per Liter
Standard Deviation 0.260
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Potassium, Week 8, n=16
|
-0.07 Millimoles per Liter
Standard Deviation 0.236
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Potassium, Week 12, n=16
|
0.01 Millimoles per Liter
Standard Deviation 0.379
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
Sodium, Week 4, n=17
|
-0.4 Millimoles per Liter
Standard Deviation 2.06
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
UEC, Week 4, n=17
|
-0.5250 Millimoles per Liter
Standard Deviation 1.01068
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
UEC, Week 8, n=16
|
-0.6694 Millimoles per Liter
Standard Deviation 1.20801
|
|
Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)
UEC, Week 12, n=16
|
-0.3570 Millimoles per Liter
Standard Deviation 1.18762
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; basophil count, eosinophil count, lymphocyte count and monocyte count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=2 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Basophils, Day 14, n=1
|
-0.30 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Basophils, Day 29, n=2
|
-0.05 Giga cells per Liter
Standard Deviation 0.212
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Eosinophils, Day 14, n=1
|
0.000 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Eosinophils, Day 29, n=2
|
0.100 Giga cells per Liter
Standard Deviation 0.1414
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Lymphocytes, Day 14, n=1
|
0.500 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Lymphocytes, Day 29, n=2
|
0.400 Giga cells per Liter
Standard Deviation 0.1414
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Monocytes, Day 14, n=1
|
0.000 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)
Monocytes, Day 29, n=2
|
-0.100 Giga cells per Liter
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4 and 8Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; basophil count, eosinophil count, lymphocyte count and monocyte count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=3 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Monocytes, Week 4, n=3
|
-0.040 Giga cells per Liter
Standard Deviation 0.2425
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Basophils, Week 4, n=3
|
0.03 Giga cells per Liter
Standard Deviation 0.058
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Basophils, Week 8, n=1
|
0.00 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Eosinophils, Week 4, n=3
|
0.000 Giga cells per Liter
Standard Deviation 0.0000
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Eosinophils, Week 8, n=1
|
0.000 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Lymphocytes, Week 4, n=3
|
0.073 Giga cells per Liter
Standard Deviation 0.3607
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Lymphocytes, Week 8, n=1
|
-0.300 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)
Monocytes, Week 8, n=1
|
0.000 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; total neutrophils count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=11 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose)
Day 14, n=9
|
-0.353 Giga cells per Liter
Standard Deviation 0.6194
|
|
Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose)
Day 29, n=11
|
-0.565 Giga cells per Liter
Standard Deviation 1.1071
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; total neutrophil count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=11 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose)
Week 12, n=7
|
-0.076 Giga cells per Liter
Standard Deviation 0.7115
|
|
Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose)
Week 4, n=11
|
0.539 Giga cells per Liter
Standard Deviation 0.9379
|
|
Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose)
Week 8, n=8
|
0.010 Giga cells per Liter
Standard Deviation 0.8206
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; platelet count and WBC count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)
Platelets, Day 1 (post-dose), n=1
|
39.0 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)
WBCs, Day 29, n=18
|
-0.263 Giga cells per Liter
Standard Deviation 1.1894
|
|
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)
Platelets, Day 14, n=17
|
-6.6 Giga cells per Liter
Standard Deviation 30.83
|
|
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)
Platelets, Day 29, n=18
|
8.7 Giga cells per Liter
Standard Deviation 29.14
|
|
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)
WBCs, Day 1, n=1
|
2.100 Giga cells per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)
WBCs, Day 14, n=17
|
-0.056 Giga cells per Liter
Standard Deviation 0.8815
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; platelet count and WBC count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)
Platelets, Week 4, n=17
|
11.7 Giga cells per Liter
Standard Deviation 21.00
|
|
Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)
Platelets, Week 12, n=16
|
7.3 Giga cells per Liter
Standard Deviation 18.34
|
|
Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)
Platelets, Week 8, n=16
|
12.0 Giga cells per Liter
Standard Deviation 25.72
|
|
Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)
WBCs, Week 4, n=17
|
-0.053 Giga cells per Liter
Standard Deviation 1.1486
|
|
Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)
WBCs, Week 8, n=16
|
-0.085 Giga cells per Liter
Standard Deviation 0.7777
|
|
Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)
WBCs, Week 12, n=16
|
-0.159 Giga cells per Liter
Standard Deviation 0.9395
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; hemoglobin and MCHC following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)
Hemoglobin, Day 1 (post-dose), n=1
|
-6.0 Grams per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)
Hemoglobin, Day 14, n=17
|
-5.1 Grams per Liter
Standard Deviation 7.60
|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)
Hemoglobin, Day 29, n=18
|
-3.6 Grams per Liter
Standard Deviation 6.93
|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)
MCHC, Day 1 (post-dose), n=1
|
-8.0 Grams per Liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)
MCHC, Day 14, n=17
|
-1.2 Grams per Liter
Standard Deviation 6.93
|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)
MCHC, Day 29, n=18
|
1.3 Grams per Liter
Standard Deviation 7.81
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameters; hemoglobin and MCHC following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)
MCHC, Week 8, n=16
|
-0.8 Grams per Liter
Standard Deviation 6.33
|
|
Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)
Hemoglobin, Week 4, n=17
|
-0.8 Grams per Liter
Standard Deviation 5.25
|
|
Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)
Hemoglobin, Week 8, n=16
|
0.8 Grams per Liter
Standard Deviation 6.56
|
|
Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)
Hemoglobin, Week 12, n=16
|
1.4 Grams per Liter
Standard Deviation 7.31
|
|
Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)
MCHC, Week 4, n=17
|
0.9 Grams per Liter
Standard Deviation 7.39
|
|
Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)
MCHC, Week 12, n=16
|
1.8 Grams per Liter
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; MCH following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose)
Day 14, n=17
|
-0.22 Picograms
Standard Deviation 0.629
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose)
Day 29, n=18
|
-0.01 Picograms
Standard Deviation 0.567
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose)
Day 1 (post-dose), n=1
|
-0.90 Picograms
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; MCH following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in MCH at Indicated Time Points (IM Dose)
Week 4, n=17
|
-0.15 Picograms
Standard Deviation 0.292
|
|
Change From Baseline in MCH at Indicated Time Points (IM Dose)
Week 8, n=16
|
-0.39 Picograms
Standard Deviation 0.584
|
|
Change From Baseline in MCH at Indicated Time Points (IM Dose)
Week 12, n=16
|
-0.36 Picograms
Standard Deviation 0.778
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; MCV following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose)
Day 1 (post-dose), n=1
|
-0.20 Femtoliters
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose)
Day 14, n=17
|
-0.40 Femtoliters
Standard Deviation 1.052
|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose)
Day 29, n=18
|
-0.34 Femtoliters
Standard Deviation 1.303
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; MCV following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in MCV at Indicated Time Points (IM Dose)
Week 4, n=17
|
-0.67 Femtoliters
Standard Deviation 1.771
|
|
Change From Baseline in MCV at Indicated Time Points (IM Dose)
Week 8, n=16
|
-1.03 Femtoliters
Standard Deviation 1.799
|
|
Change From Baseline in MCV at Indicated Time Points (IM Dose)
Week 12, n=16
|
-1.63 Femtoliters
Standard Deviation 1.861
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; hematocrit following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose)
Day 1 (post-dose), n=1
|
-0.0060 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose)
Day 14, n=17
|
-0.0135 Proportion of red blood cells in blood
Standard Deviation 0.02456
|
|
Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose)
Day 29, n=18
|
-0.0122 Proportion of red blood cells in blood
Standard Deviation 0.02084
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; hematocrit following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Hematocrit at Indicated Time Points (IM Dose)
Week 4, n=17
|
-0.0034 Proportion of red blood cells in blood
Standard Deviation 0.01703
|
|
Change From Baseline in Hematocrit at Indicated Time Points (IM Dose)
Week 8, n=16
|
0.0030 Proportion of red blood cells in blood
Standard Deviation 0.02145
|
|
Change From Baseline in Hematocrit at Indicated Time Points (IM Dose)
Week 12, n=16
|
0.0025 Proportion of red blood cells in blood
Standard Deviation 0.02196
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; RBC count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose)
Day 1 (post-dose), n=1
|
-0.050 Trillion cells per liter
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose)
Day 14, n=17
|
-0.126 Trillion cells per liter
Standard Deviation 0.2813
|
|
Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose)
Day 29, n=18
|
-0.114 Trillion cells per liter
Standard Deviation 0.2360
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the assessment of hematology parameter; RBC count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in RBC Count at Indicated Time Points (IM Dose)
Week 4, n=17
|
-0.004 Trillion cells per liter
Standard Deviation 0.1718
|
|
Change From Baseline in RBC Count at Indicated Time Points (IM Dose)
Week 8, n=16
|
0.087 Trillion cells per liter
Standard Deviation 0.2129
|
|
Change From Baseline in RBC Count at Indicated Time Points (IM Dose)
Week 12, n=16
|
0.117 Trillion cells per liter
Standard Deviation 0.2266
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
SBP and DBP were measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose)
SBP, Day 29
|
-1.0 Millimeters of mercury
Standard Deviation 8.64
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose)
SBP, Day 14
|
-1.3 Millimeters of mercury
Standard Deviation 8.55
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose)
DBP, Day 14
|
-0.9 Millimeters of mercury
Standard Deviation 7.57
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose)
DBP, Day 29
|
0.5 Millimeters of mercury
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Week 4, n=17
|
1.8 Millimeters of mercury
Standard Deviation 12.11
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Week 8, n=16
|
0.9 Millimeters of mercury
Standard Deviation 9.23
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Day 3, n=17
|
0.1 Millimeters of mercury
Standard Deviation 10.15
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Day 5, n=17
|
-1.5 Millimeters of mercury
Standard Deviation 10.44
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Day 8, n=17
|
3.2 Millimeters of mercury
Standard Deviation 13.18
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Week 12, n=16
|
-1.1 Millimeters of mercury
Standard Deviation 11.69
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Week 24, n=16
|
2.0 Millimeters of mercury
Standard Deviation 12.88
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Week 36, n=16
|
1.7 Millimeters of mercury
Standard Deviation 11.44
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
SBP, Week 52, n=15
|
0.7 Millimeters of mercury
Standard Deviation 13.08
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Day 3, n=17
|
0.5 Millimeters of mercury
Standard Deviation 4.11
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Day 5, n=17
|
-0.7 Millimeters of mercury
Standard Deviation 4.69
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Day 8, n=17
|
0.6 Millimeters of mercury
Standard Deviation 5.36
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Week 4, n=17
|
-0.4 Millimeters of mercury
Standard Deviation 5.20
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Week 8, n=16
|
3.3 Millimeters of mercury
Standard Deviation 5.65
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Week 12, n=16
|
0.2 Millimeters of mercury
Standard Deviation 4.46
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Week 24, n=16
|
1.0 Millimeters of mercury
Standard Deviation 4.98
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Week 36, n=16
|
2.3 Millimeters of mercury
Standard Deviation 5.47
|
|
Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)
DBP, Week 52, n=15
|
0.1 Millimeters of mercury
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Pulse rate was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose)
Day 14
|
-1.0 Beats per minute
Standard Deviation 5.72
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose)
Day 29
|
2.4 Beats per minute
Standard Deviation 8.23
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pulse rate was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Day 3, n=17
|
-0.9 Beats per minute
Standard Deviation 10.51
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Day 5, n=17
|
6.2 Beats per minute
Standard Deviation 7.66
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Day 8, n=17
|
1.6 Beats per minute
Standard Deviation 9.06
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Week 4, n=17
|
-0.6 Beats per minute
Standard Deviation 7.40
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Week 8, n=16
|
-0.9 Beats per minute
Standard Deviation 7.85
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Week 12, n=16
|
1.3 Beats per minute
Standard Deviation 11.80
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Week 24, n=16
|
1.1 Beats per minute
Standard Deviation 6.87
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Week 36, n=16
|
2.6 Beats per minute
Standard Deviation 11.07
|
|
Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)
Week 52, n=15
|
1.9 Beats per minute
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 29Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Body temperature was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=18 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose)
Day 14
|
-0.2 Degrees Celsius
Standard Deviation 0.54
|
|
Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose)
Day 29
|
-0.1 Degrees Celsius
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Body temperature was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cabotegravir IM 600 mg
n=17 Participants
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Week 24, n=16
|
-0.0 Degrees Celsius
Standard Deviation 0.39
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Week 36, n=16
|
-0.1 Degrees Celsius
Standard Deviation 0.58
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Week 52, n=15
|
0.1 Degrees Celsius
Standard Deviation 0.61
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Day 3, n=17
|
-0.0 Degrees Celsius
Standard Deviation 0.36
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Day 5, n=17
|
0.2 Degrees Celsius
Standard Deviation 0.52
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Day 8, n=17
|
0.0 Degrees Celsius
Standard Deviation 0.37
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Week 4, n=17
|
-0.1 Degrees Celsius
Standard Deviation 0.31
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Week 8, n=16
|
-0.0 Degrees Celsius
Standard Deviation 0.47
|
|
Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)
Week 12, n=16
|
0.2 Degrees Celsius
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Safety Population. This analysis was not planned and data was not collected and not captured in the database.
Urinalysis included assessment of pH, glucose, protein, blood and ketones by dipstick method. This analysis was not planned and data was not collected and not captured in the database.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Population. This analysis was not planned and data was not collected and not captured in the database.
Urinalysis included assessment of pH, glucose, protein, blood and ketones by dipstick method. This analysis was not planned and data was not collected and not captured in the database.
Outcome measures
Outcome data not reported
Adverse Events
Cabotegravir Oral 30 mg
Cabotegravir IM 600 mg
Serious adverse events
| Measure |
Cabotegravir Oral 30 mg
n=19 participants at risk
All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.
|
Cabotegravir IM 600 mg
n=17 participants at risk
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|---|
|
Eye disorders
Pupils unequal
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
Other adverse events
| Measure |
Cabotegravir Oral 30 mg
n=19 participants at risk
All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.
|
Cabotegravir IM 600 mg
n=17 participants at risk
All participants received single IM dose of 600 mg cabotegravir in Period 2.
|
|---|---|---|
|
General disorders
Injection site pain
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
88.2%
15/17 • Number of events 22 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Injection site erythema
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
11.8%
2/17 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
11.8%
2/17 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Gait disturbance
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Injection site induration
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Injection site pruritus
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Injection site swelling
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
General disorders
Thirst
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Gastroenteritis viral
|
15.8%
3/19 • Number of events 3 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Bacterial vaginosis
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
11.8%
2/17 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
11.8%
2/17 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
11.8%
2/17 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Investigations
Blood glucose increased
|
10.5%
2/19 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
11.8%
2/17 • Number of events 2 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
5.3%
1/19 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/19 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
5.9%
1/17 • Number of events 1 • Non-SAEs and SAEs were collected from the start of study treatment up to Day 29 for Period 1 (Oral dose) and up to Week 52 for Period 2 (IM dose)
Non-SAE and SAEs were reported for Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER