Trial Outcomes & Findings for A Study of LY3039478 in Healthy Participants (NCT NCT02659865)

Last Updated: 2025-08-12

Results Overview

PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched placebo QTcF from their QTcF results after receiving LY3039478. The relationship between plasma concentrations of LY3039478 and ΔQTcF was evaluated using a linear mixed-effects modeling approach. The response variable was ΔQTcF, and concentrations was fitted as a fixed effect with participants as a random effect. The regression slope was presented with the unit in "milliseconds per nanogram per milliliter" abbreviated as "ms/ng/mL".

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Results posted on

2025-08-12

Participant Flow

Participants were randomized to 1 of 3 treatment sequences with a placebo-control in at least 1 of the 3 study periods in Part A. Each period was separated by a washout period of ≥14 days. Participants were randomized to 1 of 2 treatment sequences in Part B. Each period was separated by a washout of ≥14 days.

Participant milestones

Participant milestones
Measure	Part A: Group 1 (25 mg LY3039478 First, Then 50 mg LY3039478, Followed by Placebo) Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods.	Part A: Group 2 (25 mg LY3039478 First, Then Placebo, Followed by 75 mg LY3039478) Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods.	Part A: Group 3 (Placebo First, Then 50 mg LY3039478, Followed by 75 mg LY3039478) Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods.	Part B: 50 mg LY3039478 (Reference Formulation 1 First, Then Test Formulation 3) Single oral dose of 50 mg drug-in capsule LY3039478 (reference, formulation 1) was administered in period 1, then 50 mg LY3039478 (test, formulation 3) was administered in period 2.	Part B: 50 mg LY3039478 (Test Formulation 3 First, Then Reference Formulation 1) Single oral dose of 50 mg formulated capsule LY3039478 (test, formulation 3) administered in period 1, then 50 mg LY3039478 (reference, formulation 1) was administered in period 2.
Period 1 STARTED	5	5	5	7	7
Period 1 COMPLETED	4	5	5	7	6
Period 1 NOT COMPLETED	1	0	0	0	1
Period 2 STARTED	4	5	5	7	6
Period 2 COMPLETED	4	5	5	7	6
Period 2 NOT COMPLETED	0	0	0	0	0
Period 3 STARTED	4	5	5	0	0
Period 3 COMPLETED	4	5	5	0	0
Period 3 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Group 1 (25 mg LY3039478 First, Then 50 mg LY3039478, Followed by Placebo) Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods.	Part A: Group 2 (25 mg LY3039478 First, Then Placebo, Followed by 75 mg LY3039478) Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods.	Part A: Group 3 (Placebo First, Then 50 mg LY3039478, Followed by 75 mg LY3039478) Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods.	Part B: 50 mg LY3039478 (Reference Formulation 1 First, Then Test Formulation 3) Single oral dose of 50 mg drug-in capsule LY3039478 (reference, formulation 1) was administered in period 1, then 50 mg LY3039478 (test, formulation 3) was administered in period 2.	Part B: 50 mg LY3039478 (Test Formulation 3 First, Then Reference Formulation 1) Single oral dose of 50 mg formulated capsule LY3039478 (test, formulation 3) administered in period 1, then 50 mg LY3039478 (reference, formulation 1) was administered in period 2.
Period 1 Withdrawal by Subject	1	0	0	0	0
Period 1 Adverse Event	0	0	0	0	1

Baseline Characteristics

A Study of LY3039478 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A n=15 Participants Single oral dose of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part B n=14 Participants Single oral dose of 50 mg drug-in capsule LY3039478 (reference, formulation 1) administered in one of two study periods. Single oral dose of 50 mg formulated capsule LY3039478 (test, formulation 3) administered in one of two study periods	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable mean time-matched difference in QTcF interval data in part A. Data from all dose levels were combined due to analysis is looking at QTcF as a function of concentration of LY in the blood, not as a function of dose per protocol and statistical analysis plan.

Outcome measures

Outcome measures
Measure	Part A: LY3039478 Capsule Formulation (Formulation 3)+Placebo n=15 Participants Single oral dose of placebo, 25 mg, 50 mg, and 75 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 50 mg of LY3039478 Capsule Formulation (Formulation 3) Single oral dose of 50 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 75 mg of LY3039478 Capsule Formulation (Formulation 3) Single oral dose of 75 mg of LY3039478 capsule formulation (formulation 3) or placebo administered in one of three study periods. A washout period occurred after each period.
Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A	-0.001 ms/ng/mL Interval -0.006 to 0.003	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in part A.

PK is Cmax of LY3039478 capsule formulation (formulation 3) in part A.

Outcome measures

Outcome measures
Measure	Part A: LY3039478 Capsule Formulation (Formulation 3)+Placebo n=10 Participants Single oral dose of placebo, 25 mg, 50 mg, and 75 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 50 mg of LY3039478 Capsule Formulation (Formulation 3) n=9 Participants Single oral dose of 50 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 75 mg of LY3039478 Capsule Formulation (Formulation 3) n=10 Participants Single oral dose of 75 mg of LY3039478 capsule formulation (formulation 3) or placebo administered in one of three study periods. A washout period occurred after each period.
PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A	158 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 43	296 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 31	461 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 44

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A

PK is the area under the concentration versus time curve from zero to infinity (AUC\[0-∞\]) of LY3039478 capsule formulation (formulation 3) in part A.

Outcome measures

Outcome measures
Measure	Part A: LY3039478 Capsule Formulation (Formulation 3)+Placebo n=10 Participants Single oral dose of placebo, 25 mg, 50 mg, and 75 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 50 mg of LY3039478 Capsule Formulation (Formulation 3) n=9 Participants Single oral dose of 50 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 75 mg of LY3039478 Capsule Formulation (Formulation 3) n=10 Participants Single oral dose of 75 mg of LY3039478 capsule formulation (formulation 3) or placebo administered in one of three study periods. A washout period occurred after each period.
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A	711 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 39	1400 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 21	2090 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 41

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in part B.

PK is the Cmax of the 2 formulations of LY3039478 in part B

Outcome measures

Outcome measures
Measure	Part A: LY3039478 Capsule Formulation (Formulation 3)+Placebo n=13 Participants Single oral dose of placebo, 25 mg, 50 mg, and 75 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 50 mg of LY3039478 Capsule Formulation (Formulation 3) n=14 Participants Single oral dose of 50 mg of LY3039478 capsule formulation (formulation 3) administered in one of three periods. A washout period occurred after each period.	Part A: 75 mg of LY3039478 Capsule Formulation (Formulation 3) Single oral dose of 75 mg of LY3039478 capsule formulation (formulation 3) or placebo administered in one of three study periods. A washout period occurred after each period.
PK: Cmax of the 2 Formulations of LY3039478 Part B	322 ng/mL Geometric Coefficient of Variation 25	384 ng/mL Geometric Coefficient of Variation 21	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in part B.

PK is the AUC(0-∞) of the 2 formulations of LY3039478 in part B.