Trial Outcomes & Findings for A Multiple Dose Study of LY3023703 in Healthy Participants (NCT NCT01849055)
NCT ID: NCT01849055
Last Updated: 2018-12-14
Results Overview
A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline to Study Completion (up to 74 Days)
Results posted on
2018-12-14
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo administered by mouth (PO), once a day (QD), for 28 days
|
2.5 mg LY3023703
2.5 milligram (mg) LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered by mouth (PO), once a day (QD), for 28 days
|
2.5 mg LY3023703
2.5 milligram (mg) LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Multiple Dose Study of LY3023703 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 Participants
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 Participants
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 Participants
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
n=8 Participants
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
n=8 Participants
400 mg celecoxib administered PO, QD, for 28 days
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
43.0 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
37.9 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
41.4 Years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
39.0 Years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
39.1 Years
STANDARD_DEVIATION 6.8 • n=8 Participants
|
39.7 Years
STANDARD_DEVIATION 9.8 • n=8 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=8 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
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=8 Participants
|
0 Participants
n=8 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
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (up to 74 Days)Population: Randomized participants who reported an AE that met any of the serious criteria.
A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 Participants
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 Participants
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 Participants
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
n=8 Participants
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
n=8 Participants
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-First Dose on Days 1-28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)Population: All randomized participants who received at least one dose of the study medication and had evaluable PK data.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 Participants
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 Participants
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 Participants
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703
Single Oral Dose (Day 1)
|
332 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 41.4
|
1140 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 31.7
|
2300 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 12.4
|
5290 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 24.0
|
—
|
—
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703
Multiple Oral Doses (Day 28)
|
300 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 39.3
|
1340 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 43.7
|
2880 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 19.2
|
8520 hours•nanogram/milliliter (hr•ng/mL)
Geometric Coefficient of Variation 24.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)Population: All randomized participants who received at least one dose of the study medication and had evaluable PK data.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 Participants
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 Participants
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 Participants
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703
Single Oral Dose (Day 1)
|
42.6 ng/mL
Geometric Coefficient of Variation 25.2
|
126 ng/mL
Geometric Coefficient of Variation 35.2
|
228 ng/mL
Geometric Coefficient of Variation 25.6
|
556 ng/mL
Geometric Coefficient of Variation 30.1
|
—
|
—
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703
Multiple Oral Doses (Day 28)
|
41.9 ng/mL
Geometric Coefficient of Variation 47.5
|
151 ng/mL
Geometric Coefficient of Variation 47.0
|
243 ng/mL
Geometric Coefficient of Variation 28.3
|
711 ng/mL
Geometric Coefficient of Variation 26.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)Population: All randomly assigned participants who received at least one dose of the study medication and had evaluable PK data.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 Participants
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 Participants
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 Participants
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703
Single Oral Dose (Day 1)
|
2.01 Hours
Interval 2.0 to 4.03
|
3.00 Hours
Interval 2.0 to 4.0
|
4.00 Hours
Interval 2.0 to 4.0
|
4.00 Hours
Interval 2.0 to 4.0
|
—
|
—
|
|
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703
Multiple Oral Doses (Day 28)
|
2.00 Hours
Interval 1.0 to 4.0
|
2.00 Hours
Interval 2.0 to 4.0
|
4.00 Hours
Interval 2.0 to 4.0
|
4.00 Hours
Interval 2.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 27Population: All randomized participants who received at least one dose of study treatment and had evaluable data.
The Day 27 change from Day -1 was analyzed by using analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline Day -1 as a covariate. The treatment mean, difference to placebo, and difference to celecoxib were output with corresponding 90% confidence intervals.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 Participants
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 Participants
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 Participants
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
n=8 Participants
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
n=8 Participants
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Day 27 in Blood Pressure (BP)
Systolic Blood Pressure (SBP)
|
-1.45 millimeters of mercury (mmHg)
Interval -4.02 to 1.12
|
-2.67 millimeters of mercury (mmHg)
Interval -5.56 to 0.21
|
-2.54 millimeters of mercury (mmHg)
Interval -5.11 to 0.04
|
-2.99 millimeters of mercury (mmHg)
Interval -5.65 to -0.33
|
-2.98 millimeters of mercury (mmHg)
Interval -5.54 to -0.42
|
-5.29 millimeters of mercury (mmHg)
Interval -8.1 to -2.48
|
|
Change From Baseline to Day 27 in Blood Pressure (BP)
Diastolic Blood Pressure (DBP)
|
0.28 millimeters of mercury (mmHg)
Interval -1.59 to 2.14
|
-0.11 millimeters of mercury (mmHg)
Interval -2.03 to 1.82
|
-0.83 millimeters of mercury (mmHg)
Interval -2.64 to 0.98
|
-0.68 millimeters of mercury (mmHg)
Interval -2.62 to 1.27
|
-1.22 millimeters of mercury (mmHg)
Interval -3.03 to 0.59
|
-2.24 millimeters of mercury (mmHg)
Interval -4.1 to -0.37
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2.5 mg LY3023703
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
7.5 mg LY3023703
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
15 mg LY3023703
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
30 mg LY3023703
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
400 mg Celecoxib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo administered PO, QD, for 28 days
|
2.5 mg LY3023703
n=8 participants at risk
2.5 mg LY3023703 administered PO, QD, for 28 days
|
7.5 mg LY3023703
n=8 participants at risk
7.5 mg LY3023703 administered PO, QD, for 28 days
|
15 mg LY3023703
n=8 participants at risk
15 mg LY3023703 administered PO, QD, for 28 days
|
30 mg LY3023703
n=8 participants at risk
30 mg LY3023703 administered PO, QD, for 28 days
|
400 mg Celecoxib
n=8 participants at risk
400 mg celecoxib administered PO, QD, for 28 days
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Faeces discoloured
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Oedema peripheral
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Blood immunoglobulin e increased
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 4
|
12.5%
1/8 • Number of events 2
|
12.5%
1/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
37.5%
3/8 • Number of events 4
|
0.00%
0/8
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
—
0/0
|
0.00%
0/1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
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