Trial Outcomes & Findings for A Study of LY3314814 in Healthy Participants (NCT NCT03222427)
NCT ID: NCT03222427
Last Updated: 2019-10-31
Results Overview
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.
COMPLETED
PHASE1
8 participants
Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
2019-10-31
Participant Flow
Participant milestones
| Measure |
LY3314814 + [13C415N3] LY3314814
Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of \[13C415N3\] LY3314814 over 2 hours on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
Received One Dose of Study Drug
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3314814 in Healthy Participants
Baseline characteristics by cohort
| Measure |
LY3314814 + [13C415N3] LY3314814
n=8 Participants
Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of \[13C415N3\] LY3314814 over 2 hours on Day 1.
|
|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dosePopulation: All participants who received at least one dose of study drug and have evaluable PK data.
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.
Outcome measures
| Measure |
LY3314814
n=8 Participants
Single 50 mg dose of LY3314814 administered orally.
|
[13C415N3] LY3314814
n=7 Participants
Single 100 μg IV dose of \[13C415N3\] LY3314814 administered as an IV infusion.
|
|---|---|---|
|
Absolute Bioavailability of LY3314814
|
60.5 nanogram*hour per milliliter per mg
Geometric Coefficient of Variation 41
|
59.2 nanogram*hour per milliliter per mg
Geometric Coefficient of Variation 17
|
SECONDARY outcome
Timeframe: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dosePopulation: All participants who received one dose of study drug and had evaluable PK data.
Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC\[0 ∞\]) of LY3314814 and \[13C415N3\] LY3314814
Outcome measures
| Measure |
LY3314814
n=8 Participants
Single 50 mg dose of LY3314814 administered orally.
|
[13C415N3] LY3314814
n=7 Participants
Single 100 μg IV dose of \[13C415N3\] LY3314814 administered as an IV infusion.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
|
3020 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
5.92 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
Adverse Events
LY3314814 + [13C415N3] LY3314814
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY3314814 + [13C415N3] LY3314814
n=8 participants at risk
Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of \[13C415N3\] LY3314814 over 2 hours on Day 1.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • From baseline to end of study (Up To 7 days)
All participants who have received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
12.5%
1/8 • Number of events 1 • From baseline to end of study (Up To 7 days)
All participants who have received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • Number of events 1 • From baseline to end of study (Up To 7 days)
All participants who have received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60