Trial Outcomes & Findings for A Study of LY3337641 in Healthy Participants (NCT NCT03099148)
NCT ID: NCT03099148
Last Updated: 2023-10-17
Results Overview
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Results posted on
2023-10-17
Participant Flow
4 period, 4 sequence, randomized crossover study with at least 5 days between doses.
Participant milestones
| Measure |
Sequence ADBC
A: Reference formulation,1/2 tablet PO in fasted state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state
|
Sequence BACD
B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state A: Reference formulation,1/2 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state
|
Sequence CBDA
C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state A: Reference formulation,1/2 tablet PO in fasted state
|
Sequence DCAB
D: 20 mg LY3337641(T2fasted),1 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state A: Reference formulation,1/2 tablet PO in fasted state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state
|
|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
7
|
8
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
7
|
7
|
7
|
8
|
|
Period 1
COMPLETED
|
7
|
7
|
7
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out
STARTED
|
7
|
5
|
7
|
8
|
|
Wash-out
COMPLETED
|
7
|
5
|
7
|
8
|
|
Wash-out
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
6
|
7
|
8
|
|
Period 2
COMPLETED
|
7
|
6
|
7
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
5
|
7
|
8
|
|
Period 3
COMPLETED
|
7
|
5
|
7
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
7
|
5
|
7
|
8
|
|
Period 4
COMPLETED
|
7
|
5
|
7
|
8
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence ADBC
A: Reference formulation,1/2 tablet PO in fasted state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state
|
Sequence BACD
B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state A: Reference formulation,1/2 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state
|
Sequence CBDA
C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state A: Reference formulation,1/2 tablet PO in fasted state
|
Sequence DCAB
D: 20 mg LY3337641(T2fasted),1 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state A: Reference formulation,1/2 tablet PO in fasted state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state
|
|---|---|---|---|---|
|
Wash-out
scheduling conflict
|
0
|
1
|
0
|
0
|
|
Wash-out
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY3337641 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=29 Participants
All randomized participants who received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 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
|
29 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
29 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.53 kilograms per meter squared
STANDARD_DEVIATION 2.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Outcome measures
| Measure |
Reference Formulation (R-fasted)
n=28 Participants
A single, PO dose reference formulation (R) with water after an overnight fast in one of four periods.
|
LY3337641 (T1-fasted)
n=29 Participants
A single, PO dose of 20 mg LY3337641 (T1) with water after an overnight fast in one of four periods.
|
LY3337641 (T1-fed)
n=27 Participants
A single, PO dose of 20 mg LY3337641 (T1) with water after a high fat meal in one of four periods.
|
LY3337641 (T2-fasted)
n=27 Participants
A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
|
66.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
64.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
56.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
65.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641
Outcome measures
| Measure |
Reference Formulation (R-fasted)
n=28 Participants
A single, PO dose reference formulation (R) with water after an overnight fast in one of four periods.
|
LY3337641 (T1-fasted)
n=29 Participants
A single, PO dose of 20 mg LY3337641 (T1) with water after an overnight fast in one of four periods.
|
LY3337641 (T1-fed)
n=27 Participants
A single, PO dose of 20 mg LY3337641 (T1) with water after a high fat meal in one of four periods.
|
LY3337641 (T2-fasted)
n=27 Participants
A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
|
373 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 44
|
371 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
351 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
361 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 43
|
Adverse Events
Reference Formulation (R-fasted)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LY3337641 (T1-fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY3337641 (T1-fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LY3337641 (T2-fasted)
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 |
Reference Formulation (R-fasted)
n=28 participants at risk
A single, PO dose reference formulation (R) with water after an overnight fast in one of four periods
|
LY3337641 (T1-fasted)
n=29 participants at risk
A single, PO dose of 20 mg LY3337641 (T1) with water after an overnight fast in one of four periods.
|
LY3337641 (T1-fed)
n=27 participants at risk
A single, PO dose of 20 mg LY3337641 (T1) with water after a high fat meal in one of four periods.
|
LY3337641 (T2-fasted)
n=27 participants at risk
A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods
|
|---|---|---|---|---|
|
General disorders
Catheter site bruise
|
3.6%
1/28 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/27 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site erythema
|
3.6%
1/28 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Number of events 2 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site swelling
|
3.6%
1/28 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Number of events 2 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/29 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/27 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/27 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
2/28 • Number of events 2 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/29 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/27 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/27 • 2 months
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60