Trial Outcomes & Findings for Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants (NCT NCT04526210)
NCT ID: NCT04526210
Last Updated: 2023-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Pre-dose (Day 1) up to 336 hours post-dose
Results posted on
2023-08-31
Participant Flow
Eligible participants were randomized to 1 of the two treatment sequences (A-B or B-A) on Day 1 prior to dosing in Period 1. Participants were scheduled to receive a single treatment (A or B) on Day 1 of each treatment period in the crossover design.
Participant milestones
| Measure |
Treatment Sequence A-B
Treatment A: Participants received a single oral dose of 1 × 150 milligrams (mg) bupropion hydrochloride (HCl) salt tablet in a fasted state on Day 1 of treatment period 1. Treatment B: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg enteric coated (EC) tablets of ALXN1840 in a fasted state on Day 1 of treatment period 2. There was a washout period of 14 days between the 2 treatment periods.
|
Treatment Sequence B-A
Treatment B: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1. Treatment A: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 2. There was a washout period of 14 days between the 2 treatment periods.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
Received at Least 1 Dose of Stud Drug
|
27
|
27
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Treatment Sequence A-B
Treatment A: Participants received a single oral dose of 1 × 150 milligrams (mg) bupropion hydrochloride (HCl) salt tablet in a fasted state on Day 1 of treatment period 1. Treatment B: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg enteric coated (EC) tablets of ALXN1840 in a fasted state on Day 1 of treatment period 2. There was a washout period of 14 days between the 2 treatment periods.
|
Treatment Sequence B-A
Treatment B: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1. Treatment A: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 2. There was a washout period of 14 days between the 2 treatment periods.
|
|---|---|---|
|
Overall Study
Sponsor decision
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Baseline characteristics by cohort
| Measure |
Treatment Sequence A-B
n=27 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1. Treatment B: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 2. There was a washout period of 14 days between the 2 treatment periods.
|
Treatment Sequence B-A
n=27 Participants
Treatment B: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1. Treatment A: Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 2. There was a washout period of 14 days between the 2 treatment periods.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 8.68 • n=99 Participants
|
33.1 years
STANDARD_DEVIATION 9.22 • n=107 Participants
|
32.3 years
STANDARD_DEVIATION 8.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: Pharmacokinetic (PK) analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=37 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=36 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Bupropion With and Without the Coadministration of ALXN1840
|
98.64 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 31.6
|
98.02 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 27.9
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=37 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=36 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) of Bupropion With and Without the Coadministration of ALXN1840
|
1021 hours*ng/mL
Geometric Coefficient of Variation 33.4
|
1010 hours*ng/mL
Geometric Coefficient of Variation 31.6
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=37 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=36 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUCinf) of Bupropion With and Without the Coadministration of ALXN1840
|
1049 hours*ng/mL
Geometric Coefficient of Variation 32.9
|
1039 hours*ng/mL
Geometric Coefficient of Variation 31.3
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=37 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=36 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Cmax of Hydroxybupropion With and Without the Coadministration of ALXN1840
|
286.5 ng/mL
Geometric Coefficient of Variation 53.8
|
284.3 ng/mL
Geometric Coefficient of Variation 53.6
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=37 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=36 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
AUCt of Hydroxybupropion With and Without the Coadministration of ALXN1840
|
11900 hours*ng/mL
Geometric Coefficient of Variation 60.2
|
11560 hours*ng/mL
Geometric Coefficient of Variation 55.3
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=37 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=36 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
AUCinf of Hydroxybupropion With and Without the Coadministration of ALXN1840
|
11960 hours*ng/mL
Geometric Coefficient of Variation 59.5
|
11630 hours*ng/mL
Geometric Coefficient of Variation 54.8
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Plasma total molybdenum was assessed as surrogate measures for ALXN1840 PK following coadministration with bupropion HCl salt tablet (Treatment B) only.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=46 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Cmax of Plasma Total Molybdenum With Coadministration of Bupropion
|
325.6 ng/mL
Geometric Coefficient of Variation 51.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Plasma total molybdenum was assessed as surrogate measures for ALXN1840 PK following coadministration with bupropion HCl salt tablet (Treatment B) only.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=46 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
AUCt of Plasma Total Molybdenum With Coadministration of Bupropion
|
15010 hours*ng/mL
Geometric Coefficient of Variation 68.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) up to 336 hours post-dosePopulation: PK analysis set included all participants who had sufficient plasma samples to have evaluable PK data for bupropion and/or total molybdenum (as a measure of ALXN1840) in plasma. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Plasma total molybdenum was assessed as surrogate measures for ALXN1840 PK following coadministration with bupropion HCl salt tablet (Treatment B) only.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=45 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
AUCinf of Plasma Total Molybdenum With Coadministration of Bupropion
|
16130 hours*ng/mL
Geometric Coefficient of Variation 65.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 15Population: Safety set included all participants who received at least 1 dose of study intervention.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as any AE that began or worsened on or after the first dose of treatment until the end of study (EOS) or early termination (ET). An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Treatment A: Bupropion HCl
n=50 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=50 Participants
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
8 participants
|
11 participants
|
Adverse Events
Treatment A: Bupropion HCl
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment B: Bupropion HCl + ALXN1840
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Bupropion HCl
n=50 participants at risk
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet in a fasted state on Day 1 of treatment period 1 or 2.
|
Treatment B: Bupropion HCl + ALXN1840
n=50 participants at risk
Participants received a single oral dose of 1 × 150 mg bupropion HCl salt tablet coadministered with 4 × 15 mg EC tablets of ALXN1840 in a fasted state on Day 1 of treatment period 1 or 2.
|
|---|---|---|
|
Eye disorders
Chalazion
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
4.0%
2/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Infections and infestations
Oral herpes
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
8.0%
4/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
4.0%
2/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
4.0%
2/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Psychiatric disorders
Agitation
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
4.0%
2/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.0%
1/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
0.00%
0/50 • Day 1 up to Day 15
Safety set included all participants who received at least 1 dose of study intervention. All randomized participants except 8 received both assigned doses; 4 participants received only Treatment A and 4 participants received only Treatment B. In total, 50 participants received Treatment A and 50 participants received Treatment B. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place