Trial Outcomes & Findings for A Study of LY3009104 in Healthy Participants (NCT NCT01536951)
NCT ID: NCT01536951
Last Updated: 2017-06-06
Results Overview
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period \[-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h\]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose
Results posted on
2017-06-06
Participant Flow
The study had 2 parts. Part A: single-dose, dose-escalating study of LY3009104 \[up to 40 milligrams (mg)\] or placebo administered in each period. Part B: assessed the electrophysiological effects of a single supratherapeutic LY3009104 dose compared to a positive control (moxifloxacin) and placebo. Participants enrolled in either Part A or Part B.
Participant milestones
| Measure |
Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104
First Intervention: Placebo tablets \[matching 20-mg LY3009104\] administered orally once.
Second Intervention: 30-mg LY3009104 dose administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo
First Intervention: 20-mg LY3009104 dose administered orally once.
Second Intervention: 30-mg LY3009104 dose administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104
First Intervention: 20-mg LY3009104 dose administered orally once.
Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: 40 mg LY3009104, Placebo, Moxifloxacin
First Intervention: 40-mg LY3009104 dose administered orally once.
Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Placebo, Moxifloxacin, 40 mg LY3009104
First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Moxifloxacin, 40 mg LY3009104, Placebo
First Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Second Intervention: 40-mg LY3009104 dose administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Moxifloxacin, Placebo, 40 mg LY3009104
First Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: 40 mg LY3009104, Moxifloxacin, Placebo
First Intervention: 40-mg LY3009104 dose administered orally once.
Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Placebo, 40 mg LY3009104, Moxifloxacin
First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Second Intervention: 40-mg LY3009104 dose administered orally once.
Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.
There was a washout of at least 3 days between each intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
First Intervention and Washout Period 1
STARTED
|
3
|
3
|
3
|
8
|
9
|
9
|
9
|
9
|
9
|
|
First Intervention and Washout Period 1
Received at Least 1 Dose of Study Drug
|
3
|
3
|
3
|
8
|
9
|
9
|
9
|
9
|
9
|
|
First Intervention and Washout Period 1
COMPLETED
|
3
|
3
|
2
|
8
|
9
|
9
|
9
|
9
|
9
|
|
First Intervention and Washout Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention and Washout Period 2
STARTED
|
3
|
3
|
2
|
8
|
9
|
9
|
9
|
9
|
9
|
|
Second Intervention and Washout Period 2
COMPLETED
|
3
|
3
|
2
|
8
|
9
|
9
|
9
|
8
|
9
|
|
Second Intervention and Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Third Intervention
STARTED
|
3
|
3
|
2
|
8
|
9
|
9
|
9
|
8
|
9
|
|
Third Intervention
COMPLETED
|
3
|
3
|
2
|
8
|
9
|
9
|
9
|
8
|
9
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104
First Intervention: Placebo tablets \[matching 20-mg LY3009104\] administered orally once.
Second Intervention: 30-mg LY3009104 dose administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo
First Intervention: 20-mg LY3009104 dose administered orally once.
Second Intervention: 30-mg LY3009104 dose administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104
First Intervention: 20-mg LY3009104 dose administered orally once.
Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: 40 mg LY3009104, Placebo, Moxifloxacin
First Intervention: 40-mg LY3009104 dose administered orally once.
Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Placebo, Moxifloxacin, 40 mg LY3009104
First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Moxifloxacin, 40 mg LY3009104, Placebo
First Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Second Intervention: 40-mg LY3009104 dose administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Moxifloxacin, Placebo, 40 mg LY3009104
First Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: 40 mg LY3009104, Moxifloxacin, Placebo
First Intervention: 40-mg LY3009104 dose administered orally once.
Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention.
|
Part B: Placebo, 40 mg LY3009104, Moxifloxacin
First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Second Intervention: 40-mg LY3009104 dose administered orally once.
Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.
There was a washout of at least 3 days between each intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
First Intervention and Washout Period 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention and Washout Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3009104 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A (LY3009104 or Placebo)
n=9 Participants
Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose.
|
Part B (LY3009104, Moxifloxacin, or Placebo)
n=53 Participants
Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
39.9 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
40.8 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdosePopulation: Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo).
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period \[-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h\]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.
Outcome measures
| Measure |
Part B: Placebo
n=52 Participants
Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=53 Participants
A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
n=53 Participants
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Placebo
Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
1 h postdose (n=52, 53, 53)
|
-2.5 milliseconds (msec)
Standard Deviation 4.9
|
-2.4 milliseconds (msec)
Standard Deviation 5.0
|
9.7 milliseconds (msec)
Standard Deviation 5.8
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
1.5 h postdose (n=52, 53, 53)
|
-1.7 milliseconds (msec)
Standard Deviation 3.9
|
0.1 milliseconds (msec)
Standard Deviation 5.5
|
9.3 milliseconds (msec)
Standard Deviation 5.8
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
2 h postdose (n=52, 53, 53)
|
-1.4 milliseconds (msec)
Standard Deviation 6.5
|
-0.1 milliseconds (msec)
Standard Deviation 5.3
|
9.5 milliseconds (msec)
Standard Deviation 6.9
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
3 h postdose (n=52, 53, 53)
|
-2.8 milliseconds (msec)
Standard Deviation 5.7
|
-2.5 milliseconds (msec)
Standard Deviation 4.9
|
9.2 milliseconds (msec)
Standard Deviation 6.2
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
4 h postdose (n=52, 53, 53)
|
-1.3 milliseconds (msec)
Standard Deviation 5.2
|
-0.8 milliseconds (msec)
Standard Deviation 6.2
|
9.9 milliseconds (msec)
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
6 h postdose (n=51, 53, 53)
|
-1.3 milliseconds (msec)
Standard Deviation 8.3
|
-2.2 milliseconds (msec)
Standard Deviation 8.1
|
5.5 milliseconds (msec)
Standard Deviation 7.3
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
12 h postdose (n=52, 52, 52)
|
-1.0 milliseconds (msec)
Standard Deviation 8.3
|
0.8 milliseconds (msec)
Standard Deviation 6.6
|
5.9 milliseconds (msec)
Standard Deviation 7.6
|
—
|
—
|
—
|
—
|
|
Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
24 h postdose (n=52, 53, 53)
|
-1.6 milliseconds (msec)
Standard Deviation 6.1
|
-0.8 milliseconds (msec)
Standard Deviation 6.7
|
3.4 milliseconds (msec)
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drugPopulation: Randomized participants who received at least 1 dose of LY3009104.
Outcome measures
| Measure |
Part B: Placebo
n=6 Participants
Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=6 Participants
A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
n=5 Participants
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=53 Participants
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Placebo
Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
|
578 nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 28
|
734 nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 14
|
1270 nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 13
|
741 nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drugPopulation: Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment.
Outcome measures
| Measure |
Part B: Placebo
n=5 Participants
Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=6 Participants
A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
n=5 Participants
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=53 Participants
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Placebo
Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104
|
3960 hours*nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 27
|
5480 hours*nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 19
|
8490 hours*nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 14
|
6440 hours*nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through study completion and 30-day follow-upPopulation: Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study.
The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part B: Placebo
n=8 Participants
Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=6 Participants
A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
n=6 Participants
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=5 Participants
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Placebo
n=52 Participants
Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=53 Participants
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
n=53 Participants
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Drug-Related TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Drug-Related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: 20 mg LY3009104
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: 30 mg LY3009104
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: 40 mg LY3009104
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: 40 mg LY3009104
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: Moxifloxacin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=8 participants at risk
Placebo tablets \[matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104\] administered orally once in any period during Part A of the study.
|
Part A: 20 mg LY3009104
n=6 participants at risk
A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
|
Part A: 30 mg LY3009104
n=6 participants at risk
A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
|
Part A: 40 mg LY3009104
n=5 participants at risk
A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
|
Part B: Placebo
n=52 participants at risk
Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
|
Part B: 40 mg LY3009104
n=53 participants at risk
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
|
Part B: Moxifloxacin
n=53 participants at risk
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
5.8%
3/52 • Number of events 3
|
3.8%
2/53 • Number of events 2
|
7.5%
4/53 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
General disorders
Chills
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
General disorders
Fatigue
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
General disorders
Feeling cold
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
Infections and infestations
Genital herpes
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/53
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
3.8%
2/52 • Number of events 2
|
0.00%
0/53
|
0.00%
0/53
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
3.8%
2/53 • Number of events 2
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
1.9%
1/52 • Number of events 1
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/52
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60