Trial Outcomes & Findings for Study of LY3039478 in Healthy Participants (NCT NCT02906618)
NCT ID: NCT02906618
Last Updated: 2025-07-09
Results Overview
Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
Results posted on
2025-07-09
Participant Flow
Participant milestones
| Measure |
LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV
Simultaneous administration of a single oral dose of 75 milligram (mg) of LY3039478 and a 45-minute IV administration of 350 microgram (μg) 13C15N2H-LY3039478 in healthy participants.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
Received at Least One Dose of Study Drug
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of LY3039478 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=12 Participants
LY3039478 given once, orally and 13C 15N 2H-LY3039478 given once, IV.
|
|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 15.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 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
|
12 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
|
12 Participants
n=99 Participants
|
|
Height
|
177.00 centimeter (cm)
STANDARD_DEVIATION 7.41 • n=99 Participants
|
|
Body Weight
|
80.97 kilogram (kg)
STANDARD_DEVIATION 10.00 • n=99 Participants
|
|
Body Mass Index (BMI)
|
25.82 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 2.50 • n=99 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePopulation: All participants who received at least one dose of study drug.
Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.
Outcome measures
| Measure |
LY3039478 - Oral
n=12 Participants
On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.
|
13C 15N 2H-LY3039478 - IV
n=12 Participants
On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478
|
1920 nangogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
15.6 nangogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePopulation: All participants who received at least one dose of study drug.
PK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.
Outcome measures
| Measure |
LY3039478 - Oral
n=12 Participants
On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.
|
13C 15N 2H-LY3039478 - IV
n=12 Participants
On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.
|
|---|---|---|
|
PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478
|
1920 ng*hr/mL
Geometric Coefficient of Variation 23
|
15.6 ng*hr/mL
Geometric Coefficient of Variation 16
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePopulation: All participants who received at least one dose of study drug.
PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.
Outcome measures
| Measure |
LY3039478 - Oral
n=12 Participants
On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.
|
13C 15N 2H-LY3039478 - IV
n=12 Participants
On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.
|
|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV
|
444 nanogram/millilter (ng/mL)
Geometric Coefficient of Variation 23
|
7.24 nanogram/millilter (ng/mL)
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePopulation: All participants who received at least one dose of study drug.
PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.
Outcome measures
| Measure |
LY3039478 - Oral
n=12 Participants
On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.
|
13C 15N 2H-LY3039478 - IV
n=12 Participants
On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.
|
|---|---|---|
|
PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478
|
1.500 hour (hr)
Interval 1.0 to 3.5
|
0.750 hour (hr)
Interval 0.75 to 0.75
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours PostdosePopulation: All participants who received at least one dose of study drug.
PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.
Outcome measures
| Measure |
LY3039478 - Oral
n=12 Participants
On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.
|
13C 15N 2H-LY3039478 - IV
n=12 Participants
On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.
|
|---|---|---|
|
PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478
|
5.42 hr
Interval 4.93 to 6.88
|
3.31 hr
Interval 2.84 to 3.75
|
Adverse Events
LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV
n=12 participants at risk
Simultaneous administration of a single oral dose of 75 mg of LY3039478 and a 45-minute IV administration of 350 μg 13C 15N 2H-LY3039478 in healthy participants.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60