Trial Outcomes & Findings for A Study of LY3031207 in Healthy Subjects (NCT NCT01449630)
NCT ID: NCT01449630
Last Updated: 2019-07-05
Results Overview
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Baseline, up to 4 months
Results posted on
2019-07-05
Participant Flow
Three period crossover study with three dosing cohorts. The interval between the initiation of each dosing cohort was approximately 1 week, and the washout time between each dosing period was approximately 3 weeks.
Participant milestones
| Measure |
Cohort I Sequence 1
Participants received 5 mg LY3031207, Placebo and 400 mg Celecoxib as per the below dosing schedule.
Period 1: 5 mg LY3031207 , Period 2: Placebo, and Period 3: 400 mg Celecoxib
|
Cohort I Sequence 2
Participants received 5 mg LY3031207, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.
Period 1: 5 mg LY3031207, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib
|
Cohort I Sequence 3
Participants received Placebo, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.
Period 1: Placebo, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib
|
Cohort II Sequence 1
Participants received 25 mg LY3031207 and Placebo as per the below dosing schedule.
Period 1: 25 mg LY3031207, Period 2: Placebo and Period 3: Placebo
|
Cohort II Sequence 2
Participants received 25 mg LY3031207, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.
Period 1: 25 mg LY3031207, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)
|
Cohort II Sequence 3
Participants received Placebo, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.
Period 1: Placebo, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)
|
Cohort III Sequence 1
Participants received LY3031207 75 mg, Placebo and celecoxib as per the below dosing schedule.
Period 1: LY3031207 75 mg, Period 2: Placebo and Period 3: Celecoxib 400 mg
|
Cohort III Sequence 2
Participants received LY3031207 75 mg, LY3031207 900 mg and celecoxib as per the below dosing schedule.
Period 1: LY3031207 75 mg, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg
|
Cohort III Sequence 3
Participants received Placebo, LY3031207 900 mg and celecoxib as per the below dosing schedule.
Period 1: Placebo, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
6
|
2
|
2
|
5
|
2
|
2
|
6
|
2
|
|
Period 1
Received at Least 1 Dose
|
2
|
6
|
2
|
2
|
5
|
1
|
2
|
6
|
2
|
|
Period 1
COMPLETED
|
1
|
6
|
2
|
1
|
5
|
1
|
2
|
6
|
2
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
STARTED
|
1
|
6
|
2
|
1
|
5
|
1
|
2
|
6
|
2
|
|
Period 2
COMPLETED
|
1
|
6
|
2
|
1
|
5
|
1
|
1
|
6
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 3
STARTED
|
1
|
6
|
2
|
1
|
5
|
1
|
1
|
6
|
2
|
|
Period 3
COMPLETED
|
1
|
6
|
2
|
1
|
5
|
1
|
1
|
6
|
2
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort I Sequence 1
Participants received 5 mg LY3031207, Placebo and 400 mg Celecoxib as per the below dosing schedule.
Period 1: 5 mg LY3031207 , Period 2: Placebo, and Period 3: 400 mg Celecoxib
|
Cohort I Sequence 2
Participants received 5 mg LY3031207, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.
Period 1: 5 mg LY3031207, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib
|
Cohort I Sequence 3
Participants received Placebo, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.
Period 1: Placebo, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib
|
Cohort II Sequence 1
Participants received 25 mg LY3031207 and Placebo as per the below dosing schedule.
Period 1: 25 mg LY3031207, Period 2: Placebo and Period 3: Placebo
|
Cohort II Sequence 2
Participants received 25 mg LY3031207, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.
Period 1: 25 mg LY3031207, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)
|
Cohort II Sequence 3
Participants received Placebo, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.
Period 1: Placebo, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)
|
Cohort III Sequence 1
Participants received LY3031207 75 mg, Placebo and celecoxib as per the below dosing schedule.
Period 1: LY3031207 75 mg, Period 2: Placebo and Period 3: Celecoxib 400 mg
|
Cohort III Sequence 2
Participants received LY3031207 75 mg, LY3031207 900 mg and celecoxib as per the below dosing schedule.
Period 1: LY3031207 75 mg, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg
|
Cohort III Sequence 3
Participants received Placebo, LY3031207 900 mg and celecoxib as per the below dosing schedule.
Period 1: Placebo, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY3031207 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort I Sequence 1
n=2 Participants
Participants received 5 mg LY3031207, Placebo and 400 mg Celecoxib as per the below dosing schedule.
Period 1: 5 mg LY3031207 , Period 2: Placebo, and Period 3: 400 mg Celecoxib
|
Cohort I Sequence 2
n=6 Participants
Participants received 5 mg LY3031207, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.
Period 1: 5 mg LY3031207, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib
|
Cohort I Sequence 3
n=2 Participants
Participants received Placebo, 225 mg LY3031207 and 400 mg Celecoxib as per the below dosing schedule.
Period 1: Placebo, Period 2: 225 mg LY3031207 and Period 3: 400 mg Celecoxib
|
Cohort II Sequence 1
n=2 Participants
Participants received 25 mg LY3031207 and Placebo as per the below dosing schedule.
Period 1: 25 mg LY3031207, Period 2: Placebo and Period 3: Placebo
|
Cohort II Sequence 2
n=5 Participants
Participants received 25 mg LY3031207, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.
Period 1: 25 mg LY3031207, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)
|
Cohort II Sequence 3
n=2 Participants
Participants received Placebo, 450 mg LY3031207 (Fed condition) and 450 mg LY3031207 (Fasted) as per the below dosing schedule.
Period 1: Placebo, Period 2: 450 mg LY3031207 (Fed) and Period 3: 450 mg LY3031207 (Fasted)
|
Cohort III Sequence 1
n=2 Participants
Participants received LY3031207 75 mg, Placebo and celecoxib as per the below dosing schedule.
Period 1: LY3031207 75 mg, Period 2: Placebo and Period 3: Celecoxib 400 mg
|
Cohort III Sequence 2
n=6 Participants
Participants received LY3031207 75 mg, LY3031207 900 mg and celecoxib as per the below dosing schedule.
Period 1: LY3031207 75 mg, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg
|
Cohort III Sequence 3
n=2 Participants
Participants received Placebo, LY3031207 900 mg and celecoxib as per the below dosing schedule.
Period 1: Placebo, Period 2: LY3031207 900 mg and Period 3: Celecoxib 400 mg
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
29 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
20 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
26 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
29 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 4 monthsPopulation: All participants who received at least 1 dose of study drug or placebo.
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
n=10 Participants
Matched placebo capsules administered orally.
|
400 mg Celecoxib
n=18 Participants
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE
Other Non-Serious AEs
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dosePopulation: Pharmacokinetic (PK) population: All participants who received at least 1 dose of study drug and had evaluable PK data.
AUC from time 0 to last timepoint (AUC0-tlast) with measurable concentration of LY3031207.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
Matched placebo capsules administered orally.
|
400 mg Celecoxib
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3031207
|
3040 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
13900 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 65
|
40000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
151000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
171000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
116000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 73
|
348000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 63
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dosePopulation: Pharmacokinetic (PK) population: all participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
Matched placebo capsules administered orally.
|
400 mg Celecoxib
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
|
185 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
818 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
2060 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
5610 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
7780 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
5670 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
11300 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 8, 24 and 144 hours post dose.Population: All participants who received at least 1 dose of study drug or placebo with evaluable PGE data at the specific time points.
The effect of LY3031207 on PGE synthesis in whole blood after ex vivo LPS stimulation.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
n=11 Participants
Matched placebo capsules administered orally.
|
400 mg Celecoxib
n=18 Participants
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
144 hr
|
178.2 percentage change in PGE
Standard Deviation 96.5
|
24.3 percentage change in PGE
Standard Deviation 58.2
|
153.7 percentage change in PGE
Standard Deviation 70.9
|
131.1 percentage change in PGE
Standard Deviation 111.4
|
125.1 percentage change in PGE
Standard Deviation 104.6
|
48.0 percentage change in PGE
Standard Deviation 49.3
|
41.4 percentage change in PGE
Standard Deviation 101.1
|
159.1 percentage change in PGE
Standard Deviation 138.7
|
7.6 percentage change in PGE
Standard Deviation 76.5
|
|
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
0.5 hours (hr)
|
-16.2 percentage change in PGE
Standard Deviation 32.9
|
-15.6 percentage change in PGE
Standard Deviation 26.4
|
33.0 percentage change in PGE
Standard Deviation 45.0
|
12.7 percentage change in PGE
Standard Deviation 64.0
|
42.7 percentage change in PGE
Standard Deviation 69.7
|
-85.1 percentage change in PGE
Standard Deviation 13.8
|
-43.1 percentage change in PGE
Standard Deviation 17.8
|
56.1 percentage change in PGE
Standard Deviation 97.9
|
-10.4 percentage change in PGE
Standard Deviation 77.6
|
|
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
1 hr
|
-9.2 percentage change in PGE
Standard Deviation 43.5
|
-4.8 percentage change in PGE
Standard Deviation 67.7
|
24.6 percentage change in PGE
Standard Deviation 67.5
|
-16.8 percentage change in PGE
Standard Deviation 93.7
|
-83.8 percentage change in PGE
Standard Deviation 41.4
|
-92.9 percentage change in PGE
Standard Deviation 8.5
|
-93.7 percentage change in PGE
Standard Deviation 6.9
|
65.4 percentage change in PGE
Standard Deviation 116.8
|
-44.8 percentage change in PGE
Standard Deviation 59.5
|
|
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
2 hr
|
-34.3 percentage change in PGE
Standard Deviation 20.1
|
-45.5 percentage change in PGE
Standard Deviation 49.4
|
-47.0 percentage change in PGE
Standard Deviation 19.8
|
-79.2 percentage change in PGE
Standard Deviation 21.2
|
-104.9 percentage change in PGE
Standard Deviation 11.8
|
-96.4 percentage change in PGE
Standard Deviation 8.9
|
-83.3 percentage change in PGE
Standard Deviation 11.8
|
65.1 percentage change in PGE
Standard Deviation 106.6
|
-68.2 percentage change in PGE
Standard Deviation 27.8
|
|
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
8 hr
|
-8.5 percentage change in PGE
Standard Deviation 41.0
|
-40.1 percentage change in PGE
Standard Deviation 25.4
|
-41.3 percentage change in PGE
Standard Deviation 35.9
|
-79.3 percentage change in PGE
Standard Deviation 6.6
|
-94.3 percentage change in PGE
Standard Deviation 13.9
|
-88.3 percentage change in PGE
Standard Deviation 13.5
|
-98.4 percentage change in PGE
Standard Deviation 3.8
|
76.9 percentage change in PGE
Standard Deviation 109.1
|
-63.1 percentage change in PGE
Standard Deviation 32.1
|
|
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
24 hr
|
89.4 percentage change in PGE
Standard Deviation 153.9
|
8.7 percentage change in PGE
Standard Deviation 73.3
|
60.0 percentage change in PGE
Standard Deviation 84.3
|
-29.5 percentage change in PGE
Standard Deviation NA
Not analyzed due to insufficient number of participants.
|
-76.8 percentage change in PGE
Standard Deviation 40.6
|
-54.1 percentage change in PGE
Standard Deviation 28.4
|
-88.8 percentage change in PGE
Standard Deviation 12.2
|
124.8 percentage change in PGE
Standard Deviation 139.3
|
-19.9 percentage change in PGE
Standard Deviation 60.7
|
SECONDARY outcome
Timeframe: 0 to 2, 2 to 4, 4 to 6, 6 to 12 and 12 to 24 hours post dosePopulation: All participants who received at least 1 dose of study drug or placebo with evaluable PGEM data at specific time points.
The participant's urine was collected during protocol-defined intervals and the PGE metabolite PGEM was assessed. PGEM results for each interval were then compared to the baseline value.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
n=11 Participants
Matched placebo capsules administered orally.
|
400 mg Celecoxib
n=18 Participants
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
4 - 6 hr interval
|
-0.8 percentage change in PGEM
Standard Deviation 39.3
|
-1.5 percentage change in PGEM
Standard Deviation 57.4
|
-22.1 percentage change in PGEM
Standard Deviation 35.5
|
-44.2 percentage change in PGEM
Standard Deviation 27.3
|
-9.2 percentage change in PGEM
Standard Deviation 56.9
|
15.8 percentage change in PGEM
Standard Deviation 50.8
|
-24.2 percentage change in PGEM
Standard Deviation 39.4
|
6.3 percentage change in PGEM
Standard Deviation 44.4
|
-32.3 percentage change in PGEM
Standard Deviation 42.4
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
6 - 12 hr interval
|
4.9 percentage change in PGEM
Standard Deviation 40.9
|
-17.9 percentage change in PGEM
Standard Deviation 56.4
|
-13.5 percentage change in PGEM
Standard Deviation 42.5
|
-41.9 percentage change in PGEM
Standard Deviation 23.7
|
-18.8 percentage change in PGEM
Standard Deviation 42.5
|
-13.0 percentage change in PGEM
Standard Deviation 38.0
|
-37.5 percentage change in PGEM
Standard Deviation 26.2
|
2.9 percentage change in PGEM
Standard Deviation 44.0
|
-36.8 percentage change in PGEM
Standard Deviation 27.9
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
12 - 24 hr interval
|
3.9 percentage change in PGEM
Standard Deviation 20.1
|
-32.6 percentage change in PGEM
Standard Deviation 33.5
|
-12.9 percentage change in PGEM
Standard Deviation 31.0
|
-37.9 percentage change in PGEM
Standard Deviation 29.3
|
-26.9 percentage change in PGEM
Standard Deviation 43.6
|
-7.3 percentage change in PGEM
Standard Deviation 38.2
|
-43.6 percentage change in PGEM
Standard Deviation 33.1
|
0.9 percentage change in PGEM
Standard Deviation 32.8
|
-46.5 percentage change in PGEM
Standard Deviation 17.8
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
0 - 2 hr interval
|
14.4 percentage change in PGEM
Standard Deviation 35.8
|
18.5 percentage change in PGEM
Standard Deviation 31.4
|
11.0 percentage change in PGEM
Standard Deviation 40.6
|
-26.6 percentage change in PGEM
Standard Deviation 25.9
|
17.3 percentage change in PGEM
Standard Deviation 53.5
|
10.7 percentage change in PGEM
Standard Deviation 32.7
|
-19.8 percentage change in PGEM
Standard Deviation 36.4
|
5.8 percentage change in PGEM
Standard Deviation 47.3
|
-14.6 percentage change in PGEM
Standard Deviation 40.7
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
2 - 4 hr interval
|
14.5 percentage change in PGEM
Standard Deviation 39.4
|
-2.1 percentage change in PGEM
Standard Deviation 43.4
|
5.8 percentage change in PGEM
Standard Deviation 45.5
|
-45.2 percentage change in PGEM
Standard Deviation 32.3
|
6.1 percentage change in PGEM
Standard Deviation 66.3
|
29.6 percentage change in PGEM
Standard Deviation 64.1
|
-12.0 percentage change in PGEM
Standard Deviation 41.4
|
11.2 percentage change in PGEM
Standard Deviation 32.1
|
-30.7 percentage change in PGEM
Standard Deviation 36.1
|
SECONDARY outcome
Timeframe: 0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dosePopulation: All participants who received at least 1 dose of study drug or placebo with evaluable PGIM data at specific time points
The participant's urine was collected during protocol-defined intervals and the PGE metabolite PGIM was assessed. PGIM results for each interval were then compared to the baseline value.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
n=11 Participants
Matched placebo capsules administered orally.
|
400 mg Celecoxib
n=18 Participants
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
At 0 - 2 hr interval
|
14.1 percentage change in PGIM
Standard Deviation 36.5
|
25.2 percentage change in PGIM
Standard Deviation 41.9
|
-3.9 percentage change in PGIM
Standard Deviation 27.4
|
11.7 percentage change in PGIM
Standard Deviation 28.0
|
44.6 percentage change in PGIM
Standard Deviation 44.3
|
137.2 percentage change in PGIM
Standard Deviation 195.5
|
37.2 percentage change in PGIM
Standard Deviation 30.1
|
-17.0 percentage change in PGIM
Standard Deviation 24.2
|
-18.9 percentage change in PGIM
Standard Deviation 25.6
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
At 2 - 4 hr interval
|
34.0 percentage change in PGIM
Standard Deviation 64.3
|
30.5 percentage change in PGIM
Standard Deviation 20.8
|
21.2 percentage change in PGIM
Standard Deviation 35.4
|
33.1 percentage change in PGIM
Standard Deviation 42.8
|
244.7 percentage change in PGIM
Standard Deviation 147.6
|
174.1 percentage change in PGIM
Standard Deviation 249.0
|
122.5 percentage change in PGIM
Standard Deviation 114.3
|
6.2 percentage change in PGIM
Standard Deviation 81.9
|
-44.6 percentage change in PGIM
Standard Deviation 21.3
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
At 6 - 12 hr interval
|
48.0 percentage change in PGIM
Standard Deviation 45.1
|
52.1 percentage change in PGIM
Standard Deviation 45.2
|
63.6 percentage change in PGIM
Standard Deviation 19.1
|
71.7 percentage change in PGIM
Standard Deviation 66.4
|
208.5 percentage change in PGIM
Standard Deviation 78.8
|
190.0 percentage change in PGIM
Standard Deviation 117.5
|
201.4 percentage change in PGIM
Standard Deviation 141.9
|
57.5 percentage change in PGIM
Standard Deviation 208.1
|
-12.1 percentage change in PGIM
Standard Deviation 53.8
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
At 4 - 6 hr interval
|
73.8 percentage change in PGIM
Standard Deviation 66.1
|
19.3 percentage change in PGIM
Standard Deviation 45.8
|
31.0 percentage change in PGIM
Standard Deviation 52.0
|
72.1 percentage change in PGIM
Standard Deviation 69.3
|
198.3 percentage change in PGIM
Standard Deviation 80.0
|
186.7 percentage change in PGIM
Standard Deviation 70.1
|
264.0 percentage change in PGIM
Standard Deviation 114.3
|
28.3 percentage change in PGIM
Standard Deviation 71.1
|
-25.6 percentage change in PGIM
Standard Deviation 45.4
|
SECONDARY outcome
Timeframe: 0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dosePopulation: All participants who received at least 1 dose of study drug or placebo with evaluable TXAM data at specific time points.
The participant's urine was collected during protocol-defined intervals and the PGE metabolite TXAM was assessed. TXAM results for each interval were then compared to the baseline value.
Outcome measures
| Measure |
5 mg LY3031207
n=8 Participants
5 milligrams (mg) LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 Participants
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 Participants
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 Participants
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 Participants
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted.
|
900 mg LY3031207
n=8 Participants
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
n=11 Participants
Matched placebo capsules administered orally.
|
400 mg Celecoxib
n=18 Participants
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
At 0 - 2 hr interval
|
-9.0 percentage change in TXAM
Standard Deviation 10.2
|
-5.7 percentage change in TXAM
Standard Deviation 9.6
|
0.9 percentage change in TXAM
Standard Deviation 17.4
|
-11.3 percentage change in TXAM
Standard Deviation 10.8
|
4.4 percentage change in TXAM
Standard Deviation 13.8
|
25.2 percentage change in TXAM
Standard Deviation 31.5
|
11.0 percentage change in TXAM
Standard Deviation 24.7
|
-11.5 percentage change in TXAM
Standard Deviation 22.6
|
-6.2 percentage change in TXAM
Standard Deviation 19.3
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
At 2 - 4 hr interval
|
4.1 percentage change in TXAM
Standard Deviation 16.1
|
-15.5 percentage change in TXAM
Standard Deviation 7.7
|
19.7 percentage change in TXAM
Standard Deviation 23.7
|
0.7 percentage change in TXAM
Standard Deviation 22.1
|
40.4 percentage change in TXAM
Standard Deviation 52.4
|
28.3 percentage change in TXAM
Standard Deviation 58.3
|
106.2 percentage change in TXAM
Standard Deviation 107.1
|
-17.4 percentage change in TXAM
Standard Deviation 17.2
|
-25.4 percentage change in TXAM
Standard Deviation 17.0
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
At 4 - 6 hr interval
|
1.3 percentage change in TXAM
Standard Deviation 25.4
|
-16.5 percentage change in TXAM
Standard Deviation 11.4
|
1.2 percentage change in TXAM
Standard Deviation 16.9
|
-3.8 percentage change in TXAM
Standard Deviation 16.4
|
29.4 percentage change in TXAM
Standard Deviation 29.6
|
16.7 percentage change in TXAM
Standard Deviation 25.2
|
88.5 percentage change in TXAM
Standard Deviation 47.9
|
-18.3 percentage change in TXAM
Standard Deviation 18.7
|
-33.3 percentage change in TXAM
Standard Deviation 10.6
|
|
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
At 6 - 12 hr interval
|
6.8 percentage change in TXAM
Standard Deviation 29.5
|
-15.7 percentage change in TXAM
Standard Deviation 19.6
|
20.7 percentage change in TXAM
Standard Deviation 23.2
|
8.0 percentage change in TXAM
Standard Deviation 25.2
|
30.9 percentage change in TXAM
Standard Deviation 29.6
|
9.0 percentage change in TXAM
Standard Deviation 23.1
|
85.8 percentage change in TXAM
Standard Deviation 85.9
|
13.1 percentage change in TXAM
Standard Deviation 14.8
|
-19.8 percentage change in TXAM
Standard Deviation 18.3
|
Adverse Events
5 mg LY3031207
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
25 mg LY3031207
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
75 mg LY3031207
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
225 mg LY3031207
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
450 mg LY3031207 Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
450 mg LY3031207 Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
900 mg LY3031207
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
400 mg Celecoxib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5 mg LY3031207
n=8 participants at risk
5 mg LY3031207 administered orally as capsules as a single dose.
|
25 mg LY3031207
n=6 participants at risk
25 mg LY3031207 administered orally as capsules as a single dose.
|
75 mg LY3031207
n=8 participants at risk
75 mg LY3031207 administered orally as capsules as a single dose.
|
225 mg LY3031207
n=7 participants at risk
225 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fed
n=6 participants at risk
450 mg LY3031207 administered orally as capsules as a single dose.
|
450 mg LY3031207 Fasted
n=6 participants at risk
450 mg LY3031207 administered orally as capsules as a single dose to participants who were fasted before receiving drug.
|
900 mg LY3031207
n=8 participants at risk
900 mg LY3031207 administered orally as capsules as a single dose.
|
Placebo
n=10 participants at risk
Matched placebo capsules administered orally.
|
400 mg Celecoxib
n=18 participants at risk
400 mg Celecoxib administered orally as capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
10.0%
1/10 • Number of events 1 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
10.0%
1/10 • Number of events 1 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Infections and infestations
Gingival infection
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
10.0%
1/10 • Number of events 1 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Investigations
Weight increased
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
14.3%
1/7 • Number of events 1 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
12.5%
1/8 • Number of events 1 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
10.0%
1/10 • Number of events 1 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
14.3%
1/7 • Number of events 1 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
12.5%
1/8 • Number of events 1 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
5.6%
1/18 • Number of events 1 • Up To 4 Months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Up To 4 Months
|
16.7%
1/6 • Number of events 1 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
12.5%
1/8 • Number of events 1 • Up To 4 Months
|
0.00%
0/7 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/6 • Up To 4 Months
|
0.00%
0/8 • Up To 4 Months
|
0.00%
0/10 • Up To 4 Months
|
0.00%
0/18 • Up To 4 Months
|
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