Trial Outcomes & Findings for A Study of LY3202626 in Healthy Participants (NCT NCT03023826)
NCT ID: NCT03023826
Last Updated: 2021-04-19
Results Overview
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Results posted on
2021-04-19
Participant Flow
Participants were randomized to 1 of 6 sequences in 3 periods.
Participant milestones
| Measure |
Sequence (ACB)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (CAB)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (BAC)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (ABC)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (BCA)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (CBA)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast..
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
5
|
4
|
4
|
5
|
|
Period 1
Received at Least One Dose of Study Drug
|
4
|
4
|
5
|
4
|
4
|
5
|
|
Period 1
COMPLETED
|
4
|
4
|
5
|
4
|
3
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
4
|
4
|
5
|
4
|
3
|
5
|
|
Period 2
COMPLETED
|
4
|
4
|
5
|
4
|
3
|
5
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
4
|
5
|
4
|
3
|
5
|
|
Period 3
COMPLETED
|
4
|
4
|
5
|
4
|
3
|
5
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence (ACB)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (CAB)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (BAC)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (ABC)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (BCA)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
Sequence (CBA)
A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast..
|
|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3202626 in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=26 Participants
Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions, LY3202626 tablet (T1) under fasting conditions and LY3202626 tablet (T1) following a high-fat meal.
|
|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours PostdosePopulation: All randomized participants who received at least one dose and who had evaluable PK data.
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
Outcome measures
| Measure |
12 mg LY3202626 (R-Fasting)
n=25 Participants
Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.
|
12 mg LY3202626 (T1-Fasting)
n=25 Participants
Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
|
12 mg LY3202626 (T1-Fed)
n=25 Participants
Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
|
27.9 nanogram/milliliter (ng/mL)
Standard Deviation 64
|
36.1 nanogram/milliliter (ng/mL)
Standard Deviation 45
|
39.4 nanogram/milliliter (ng/mL)
Standard Deviation 42
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626
Outcome measures
| Measure |
12 mg LY3202626 (R-Fasting)
n=25 Participants
Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.
|
12 mg LY3202626 (T1-Fasting)
n=24 Participants
Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
|
12 mg LY3202626 (T1-Fed)
n=25 Participants
Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
|
540 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 62
|
707 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 45
|
702 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 46
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and who had evaluable PK data.
PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626
Outcome measures
| Measure |
12 mg LY3202626 (R-Fasting)
n=25 Participants
Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.
|
12 mg LY3202626 (T1-Fasting)
n=25 Participants
Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
|
12 mg LY3202626 (T1-Fed)
n=25 Participants
Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
|---|---|---|---|
|
PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
|
531 h*ng/mL
Standard Deviation 62
|
667 h*ng/mL
Standard Deviation 47
|
691 h*ng/mL
Standard Deviation 45
|
Adverse Events
12 mg LY3202626 (R-Fasting)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
12 mg LY3202626 (T1-Fasting)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
12 mg LY3202626 (T1-Fed)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
12 mg LY3202626 (R-Fasting)
n=25 participants at risk
Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.
|
12 mg LY3202626 (T1-Fasting)
n=26 participants at risk
Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
|
12 mg LY3202626 (T1-Fed)
n=25 participants at risk
Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
|
|---|---|---|---|
|
General disorders
Catheter site bruise
|
4.0%
1/25 • Number of events 1 • Baseline to End of Study (Up to 3 Months)
|
3.8%
1/26 • Number of events 1 • Baseline to End of Study (Up to 3 Months)
|
12.0%
3/25 • Number of events 3 • Baseline to End of Study (Up to 3 Months)
|
|
General disorders
Catheter site erythema
|
12.0%
3/25 • Number of events 3 • Baseline to End of Study (Up to 3 Months)
|
11.5%
3/26 • Number of events 3 • Baseline to End of Study (Up to 3 Months)
|
8.0%
2/25 • Number of events 2 • Baseline to End of Study (Up to 3 Months)
|
|
General disorders
Catheter site pruritus
|
4.0%
1/25 • Number of events 1 • Baseline to End of Study (Up to 3 Months)
|
3.8%
1/26 • Number of events 1 • Baseline to End of Study (Up to 3 Months)
|
8.0%
2/25 • Number of events 2 • Baseline to End of Study (Up to 3 Months)
|
|
General disorders
Catheter site swelling
|
8.0%
2/25 • Number of events 2 • Baseline to End of Study (Up to 3 Months)
|
3.8%
1/26 • Number of events 1 • Baseline to End of Study (Up to 3 Months)
|
0.00%
0/25 • Baseline to End of Study (Up to 3 Months)
|
|
General disorders
Vessel puncture site bruise
|
16.0%
4/25 • Number of events 4 • Baseline to End of Study (Up to 3 Months)
|
3.8%
1/26 • Number of events 1 • Baseline to End of Study (Up to 3 Months)
|
20.0%
5/25 • Number of events 6 • Baseline to End of Study (Up to 3 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • Baseline to End of Study (Up to 3 Months)
|
7.7%
2/26 • Number of events 2 • Baseline to End of Study (Up to 3 Months)
|
0.00%
0/25 • Baseline to End of Study (Up to 3 Months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60