Trial Outcomes & Findings for A Study of LY2484595 in Healthy Subjects (NCT NCT01450098)
NCT ID: NCT01450098
Last Updated: 2018-10-03
Results Overview
Area under the concentration-time curve from time zero to infinity is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
Cohort A: Fixed Sequence of Meal Conditions
LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as a spray-dried solid dispersion-propyl gallate (SDSD-PG) tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast.
|
Cohort B: Comparison of Randomized Treatments
LY2484595: 100 mg of LY2484595 administered orally as reference formulation (RF) tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
|
|---|---|---|
|
Period 1
STARTED
|
8
|
31
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
8
|
31
|
|
Period 1
COMPLETED
|
8
|
31
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period of at Least 14 Days
STARTED
|
8
|
31
|
|
Washout Period of at Least 14 Days
COMPLETED
|
8
|
31
|
|
Washout Period of at Least 14 Days
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
8
|
31
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
8
|
31
|
|
Period 2
COMPLETED
|
8
|
31
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Washout of at Least 14 Days
STARTED
|
8
|
31
|
|
Washout of at Least 14 Days
COMPLETED
|
8
|
31
|
|
Washout of at Least 14 Days
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
8
|
31
|
|
Period 3
Received at Least 1 Dose of Study Drug
|
8
|
30
|
|
Period 3
COMPLETED
|
8
|
28
|
|
Period 3
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort A: Fixed Sequence of Meal Conditions
LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as a spray-dried solid dispersion-propyl gallate (SDSD-PG) tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast.
|
Cohort B: Comparison of Randomized Treatments
LY2484595: 100 mg of LY2484595 administered orally as reference formulation (RF) tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
|
|---|---|---|
|
Period 3
Protocol Violation
|
0
|
1
|
|
Period 3
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study of LY2484595 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort A: Fixed Sequence of Meal Conditions
n=8 Participants
LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast.
|
Cohort B: Comparison of Randomized Treatments
n=31 Participants
LY2484595: 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as an SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
37.3 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
36.2 years
STANDARD_DEVIATION 10.73 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian (Chinese)
|
0 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
0 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdosePopulation: All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 plasma concentration data
Area under the concentration-time curve from time zero to infinity is presented.
Outcome measures
| Measure |
LY2484595 200 mg SDSD-PG Fasted
n=7 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food
|
LY2484595 200 mg SDSD-PG Low Fat
n=8 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a low-fat breakfast
|
LY2484595 200 mg SDSD-PG High Fat
n=7 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a high-fat breakfast
|
LY2484595 300 mg SDSD-PG
Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595
|
12200 hours times nanograms per milliliter
Geometric Coefficient of Variation 29
|
17800 hours times nanograms per milliliter
Geometric Coefficient of Variation 31
|
17800 hours times nanograms per milliliter
Geometric Coefficient of Variation 29
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdosePopulation: All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 maximum observed plasma concentration data
Outcome measures
| Measure |
LY2484595 200 mg SDSD-PG Fasted
n=8 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food
|
LY2484595 200 mg SDSD-PG Low Fat
n=8 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a low-fat breakfast
|
LY2484595 200 mg SDSD-PG High Fat
n=8 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a high-fat breakfast
|
LY2484595 300 mg SDSD-PG
Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
|
|---|---|---|---|---|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595
|
828 nanograms per milliliter
Geometric Coefficient of Variation 51
|
1510 nanograms per milliliter
Geometric Coefficient of Variation 30
|
1280 nanograms per milliliter
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Baseline through completion of study (approximately 2 months)Population: All participants who received at least 1 dose of study drug
Data presented are the number of participants who experienced one or more drug-related AEs or any serious AEs. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY2484595 200 mg SDSD-PG Fasted
n=30 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food
|
LY2484595 200 mg SDSD-PG Low Fat
n=30 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a low-fat breakfast
|
LY2484595 200 mg SDSD-PG High Fat
n=8 Participants
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a high-fat breakfast
|
LY2484595 300 mg SDSD-PG
n=31 Participants
Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
|
|---|---|---|---|---|
|
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
Adverse Events
LY2484595 100 mg RF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY2484595 100 mg SDSD-PG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY2484595 200 mg SDSD-PG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2484595 300 mg SDSD-PG
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 |
LY2484595 100 mg RF
n=30 participants at risk
Cohort B: 100 mg of LY2484595 administered orally one time as an RF tablet with a low-fat breakfast
|
LY2484595 100 mg SDSD-PG
n=30 participants at risk
Cohort B: 100 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
|
LY2484595 200 mg SDSD-PG
n=8 participants at risk
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food; then, after at least a 14 day washout period, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a low-fat breakfast; then, after a washout period of at least 14 days, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a high-fat breakfast
|
LY2484595 300 mg SDSD-PG
n=31 participants at risk
Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/8
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/30
|
0.00%
0/30
|
12.5%
1/8 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/8
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Transaminases increased
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/8
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/30
|
0.00%
0/30
|
12.5%
1/8 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/8
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/30
|
0.00%
0/30
|
12.5%
1/8 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/8
|
3.2%
1/31 • 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