Trial Outcomes & Findings for A Safety Study of LY3526318 in Healthy Participants (NCT NCT04682119)
NCT ID: NCT04682119
Last Updated: 2025-09-10
Results Overview
Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Results posted on
2025-09-10
Participant Flow
This study consists of 2 parts: * Part A: Single-ascending dose (SAD, \[including a food effect (FE)\]). * Part B: Multiple-ascending dose (MAD), \[including a food effect (FE)\]). Both parts were randomized, double-blind, and placebo-controlled.
Participant milestones
| Measure |
Part A SAD: P1-L2-L3-L4
P1: Participants received placebo administered orally under fasted condition during period 1.
L2: Participants received 250 milligram (mg) LY3526318 administered orally under fasted condition during period 2.
L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3.
L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4.
|
Part A SAD: L1-P1-L3-L4
L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1.
P1: Participants received placebo administered orally under fasted condition during period 2.
L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3.
L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4.
|
Part A SAD: L1-L2-P3-L4
L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1.
L2: Participants received 250 mg LY3526318 administered orally under fasted conditions during period 2.
P3: Participants received placebo administered orally in fed state after a light breakfast during period 3.
L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4.
|
Part A SAD: L1-L2-L3-P4
L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1.
L2: Participants received 250 mg LY3526318 administered orally under fasted condition during period 2.
L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3.
P4: Participants received placebo administered orally in fed state after a high-fat breakfast during period 4.
|
Part B MAD: Placebo
Participants received placebo administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4.
|
Part B MAD: 250 mg LY3526318
Participants received 250 mg LY3526318 administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
|
2
|
2
|
2
|
6
|
|
Period 1
All Participants Who Received at Least One Dose of Study Drug
|
2
|
2
|
2
|
2
|
2
|
6
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Period 4
COMPLETED
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of LY3526318 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A SAD: Sequence P1-L2-L3-L4
n=2 Participants
P1: Participants received placebo administered orally under fasted condition during period 1.
L2: Participants received 250 mg LY3526318 administered orally under fasted condition during period 2.
L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3.
L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4.
|
Part A SAD: L1-P1-L3-L4
n=2 Participants
L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1.
P1: Participants received placebo administered orally under fasted condition during period 2.
L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3.
L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4.
|
Part A SAD: L1-L2-P3-L4
n=2 Participants
L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1.
L2: Participants received 250 mg LY3526318 administered orally under fasted conditions during period 2.
P3: Participants received placebo administered orally in fed state after a light breakfast during period 3.
L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4.
|
Part A: L1-L2-L3-P4
n=2 Participants
L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1 L2: Participants received 250 mg LY3526318 administered orally under fasted condition during period 2.
L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3.
P4: Participants received placebo administered orally in fed state after a high-fat breakfast during period 4.
|
Part B MAD: Placebo
n=2 Participants
Participants received placebo administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4
|
Part B MAD: 250 mg LY3526318
n=6 Participants
Participants received 250 mg LY3526318 administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 4 • n=5 Participants
|
31 years
STANDARD_DEVIATION 11 • n=7 Participants
|
59 years
STANDARD_DEVIATION 3 • n=5 Participants
|
43 years
STANDARD_DEVIATION 13 • n=4 Participants
|
31 years
STANDARD_DEVIATION 14 • n=21 Participants
|
35 years
STANDARD_DEVIATION 21 • n=8 Participants
|
40 years
STANDARD_DEVIATION 16.57 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dosePopulation: Part A - SAD: All participants who received at least one dose of study drug and had evaluable PK data.
Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
n=6 Participants
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
n=6 Participants
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
|
147978 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37.5
|
131271 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 61.8
|
137814 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 58.6
|
76902 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 56.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dosePopulation: Part A - SAD: All participants who received at least one dose of study drug and had evaluable PK data.
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
n=6 Participants
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
n=6 Participants
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
|
12406 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.4
|
6199 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 61.4
|
9544 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.8
|
5441 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dosePopulation: Part B - MAD: All participants who received at least one dose of study drug and had evaluable PK data.
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318
|
89614 ng*h/mL
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dosePopulation: Part B - MAD: All participants who received at least one dose of study drug and had evaluable PK data.
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
|
10717 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Single oral dose to up to 11 days of follow-upPopulation: Part A, SAD: All participants who received at least one dose of study drug.
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=4 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
n=2 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
n=2 Participants
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
n=6 Participants
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
n=6 Participants
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days following first dosePopulation: Part B, MAD: All participants who received at least one dose of study drug.
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=2 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
n=6 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dosePopulation: Part A, SAD: All participants who received 250 mg LY3526318 and had evaluable PK data.
Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax)
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=8 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)
Ratio of Fed High Fat Meal/ Fasted
|
0.6195 unitless
Interval 0.4381 to 0.8759
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)
Ratio of Fed Light Breakfast/ Fasted
|
1.2768 unitless
Interval 0.903 to 1.8052
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dosePopulation: Part A, SAD: All participants who received 250 mg LY3526318 and had evaluable PK data.
Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞)
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=8 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)
Ratio of Fed Light Breakfast/ Fasted
|
1.1341 unitless
Interval 0.9722 to 1.3229
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)
Ratio of Fed High Fat Meal/ Fasted
|
0.8454 unitless
Interval 0.7248 to 0.9862
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dosePopulation: Part A, SAD: All participants who received 250 mg LY3526318 and had evaluable PK data
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)
Outcome measures
| Measure |
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=8 Participants
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fasted
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|
|
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)
Fed Light Breakfast - Fasted
|
0.00 hours
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)
Fed High Fat Meal - Fasted
|
0.03 hours
Interval 0.0 to 2.03
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A - SAD: Placebo Fed (Light Breakfast)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - SAD: Placebo Fed (High Fat Meal)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - SAD: Placebo Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - SAD: 250 mg LY3526318 Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - SAD: 100 mg LY3526318 Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B MAD: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B MAD:250 mg LY3526318
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A - SAD: Placebo Fed (Light Breakfast)
n=2 participants at risk
Participants received placebo administered orally in fed state after a light breakfast.
|
Part A - SAD: Placebo Fed (High Fat Meal)
n=2 participants at risk
Participants received placebo administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: Placebo Fasted
n=4 participants at risk
Participants received placebo administered orally under fasted condition.
|
Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast)
n=6 participants at risk
Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast.
|
Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal)
n=6 participants at risk
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast.
|
Part A - SAD: 250 mg LY3526318 Fasted
n=6 participants at risk
Participants received 250 mg LY3526318 administered orally under fasted condition.
|
Part A - SAD: 100 mg LY3526318 Fasted
n=6 participants at risk
Participants received 100 mg LY3526318 administered orally under fasted condition.
|
Part B MAD: Placebo
n=2 participants at risk
Participants received placebo administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4.
|
Part B MAD:250 mg LY3526318
n=6 participants at risk
Participants received 250 mg LY3526318 administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
50.0%
1/2 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up To 14 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 14 Days
All randomized participants who 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