Trial Outcomes & Findings for A Multiple-dose Study of LY3031207 in Healthy Participants (NCT NCT01632566)
NCT ID: NCT01632566
Last Updated: 2019-06-27
Results Overview
A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Baseline to study completion (treatment completion and follow-up, up to 35 weeks)
Results posted on
2019-06-27
Participant Flow
Study enrolled participants of both Japanese and non-Japanese decent. Participants were pooled regardless of ethnicity. Participants assigned to 75 milligrams (mg) LY3031207 and 225 mg LY3031207 underwent identical procedures as those assigned to 25 mg LY3031207 with the addition of 10 mg open-label simvastatin administration on Days -3 and 28.
Participant milestones
| Measure |
25 mg LY3031207
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
9
|
6
|
6
|
|
Overall Study
Received at Least One Dose LY3031207
|
8
|
10
|
9
|
0
|
0
|
|
Overall Study
Received at Least One Dose Simvastatin
|
0
|
10
|
9
|
4
|
4
|
|
Overall Study
COMPLETED
|
8
|
7
|
0
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
9
|
2
|
2
|
Reasons for withdrawal
| Measure |
25 mg LY3031207
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
2
|
9
|
2
|
2
|
Baseline Characteristics
A Multiple-dose Study of LY3031207 in Healthy Participants
Baseline characteristics by cohort
| Measure |
25 mg LY3031207
n=8 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=10 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
n=9 Participants
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
n=6 Participants
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
n=6 Participants
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
39.0 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 14.7 • n=27 Participants
|
52.7 years
STANDARD_DEVIATION 5.8 • n=483 Participants
|
44.0 years
STANDARD_DEVIATION 7.8 • n=36 Participants
|
43.0 years
STANDARD_DEVIATION 11.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
38 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
20 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
39 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)Population: Participants who received at least one dose of study drug.
A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
25 mg LY3031207
n=8 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=10 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
n=9 Participants
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
n=6 Participants
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
n=6 Participants
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
n=27 Participants
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Participants with one or more AEs
|
3 Participants
|
5 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Participants with one or more serious AEs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose up to 48 hours post last dose at Day 28Population: Participants who received at least one dose of LY3031207 with evaluable Cmax data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.
Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
Outcome measures
| Measure |
25 mg LY3031207
n=8 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=6 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
|
1120 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 34.3
|
2290 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 42.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 48 hours post last dose at Day 28Population: Participants who received at least one dose of LY3031207 with evaluable AUC (0-tau) data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.
Area under the concentration versus time curve in a dosing interval (AUC\[0-tau\]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
Outcome measures
| Measure |
25 mg LY3031207
n=8 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=6 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207
|
12000 nanograms*hours/milliliter (hr*ng/mL)
Geometric Coefficient of Variation 39.7
|
30400 nanograms*hours/milliliter (hr*ng/mL)
Geometric Coefficient of Variation 45.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 48 hours post last dose at Day 28Population: Participants who received at least one dose of LY3031207 with evaluable Tmax data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.
Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
Outcome measures
| Measure |
25 mg LY3031207
n=8 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=6 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207
|
2.00 hours
Interval 1.02 to 4.0
|
3.00 hours
Interval 2.0 to 12.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 48 hours post dose at Day -3 and Day 28Population: Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.
Outcome measures
| Measure |
25 mg LY3031207
n=5 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=5 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
|
1.78 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 55.3
|
3.4 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 69.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 48 hours post dose at Day -3 and Day 28Population: Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.
Area under the concentration versus time curve over the range of all measureable concentrations (AUC\[0-tlast\]) of simvastatin.
Outcome measures
| Measure |
25 mg LY3031207
n=5 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=5 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin
|
5.23 nanograms*hours/milliliter (hr*ng/mL)
Geometric Coefficient of Variation 48.9
|
8.97 nanograms*hours/milliliter (hr*ng/mL)
Geometric Coefficient of Variation 70.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 48 hours post dose at Day -3 and Day 28Population: Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.
Outcome measures
| Measure |
25 mg LY3031207
n=5 Participants
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=5 Participants
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
Placebo With or Without Simvastatin
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
400 mg Celecoxib With or Without Simvastatin
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
|
2.00 hours
Interval 1.0 to 2.0
|
1.15 hours
Interval 1.08 to 2.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Predose up to 12 hours prior to last dose at Day 28Population: Zero participants were analyzed. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Predose up to time of last dose at Day 28Population: Zero participants were analyzed. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Predose up to 12 hours prior to last dose at Day 28Population: Zero participants were analyzed. Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Placebo With or Without Simvastatin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
25 mg LY3031207
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
75 mg LY3031207 and Simvastatin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
225 mg LY3031207 and Simvastatin
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
400 mg Celecoxib With or Without Simvastatin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg Simvastatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo With or Without Simvastatin
n=6 participants at risk
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
25 mg LY3031207
n=8 participants at risk
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=10 participants at risk
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
n=9 participants at risk
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
400 mg Celecoxib With or Without Simvastatin
n=6 participants at risk
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
n=27 participants at risk
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
0.00%
0/27
|
Other adverse events
| Measure |
Placebo With or Without Simvastatin
n=6 participants at risk
Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
25 mg LY3031207
n=8 participants at risk
Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.
|
75 mg LY3031207 and Simvastatin
n=10 participants at risk
Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
225 mg LY3031207 and Simvastatin
n=9 participants at risk
Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.
|
400 mg Celecoxib With or Without Simvastatin
n=6 participants at risk
Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.
|
10 mg Simvastatin
n=27 participants at risk
Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
33.3%
3/9 • Number of events 3
|
0.00%
0/6
|
0.00%
0/27
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/27
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Irritability
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/27
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
0.00%
0/6
|
0.00%
0/27
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
0.00%
0/27
|
|
Infections and infestations
Viral infection
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
44.4%
4/9 • Number of events 5
|
0.00%
0/6
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
0.00%
0/27
|
|
Vascular disorders
Hot flush
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/27
|
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