Trial Outcomes & Findings for A Study of LY2940680 in Healthy Participants (NCT NCT01681186)
NCT ID: NCT01681186
Last Updated: 2019-10-21
Results Overview
Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)
Results posted on
2019-10-21
Participant Flow
This randomized single-dose study consisted of 2 parts. Part A had Cohorts 1 and 2 receive ascending doses of LY2940680 and placebo over 2 periods. Part B had Cohort 3 receive 1 of 2 treatment sequences over 4 separate periods to evaluate tablet versus capsule (reference) formulation, and the effects of food and proton pump inhibitor (PPI).
Participant milestones
| Measure |
Part A, Cohort 1, Sequence 1
50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 1, Sequence 2
50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 1, Sequence 3
Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 4
100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 5
100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 6
Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part B, Cohort 3, Sequence 1
100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
|
Part B, Cohort 3, Sequence 2
100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
|
|---|---|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
4
|
2
|
2
|
3
|
3
|
2
|
7
|
7
|
|
First Intervention
COMPLETED
|
4
|
2
|
2
|
3
|
3
|
2
|
7
|
7
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period From First Intervention
STARTED
|
4
|
2
|
2
|
3
|
3
|
2
|
7
|
7
|
|
Washout Period From First Intervention
COMPLETED
|
4
|
2
|
2
|
3
|
3
|
2
|
7
|
7
|
|
Washout Period From First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
2
|
2
|
3
|
3
|
2
|
7
|
7
|
|
Second Intervention
COMPLETED
|
4
|
2
|
2
|
3
|
3
|
2
|
7
|
7
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period From Second Intervention
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
|
Washout Period From Second Intervention
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Washout Period From Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Third Intervention
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Third Intervention
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period From Third Intervention
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Washout Period From Third Intervention
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
6
|
|
Washout Period From Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Fourth Intervention
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
6
|
|
Fourth Intervention
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part A, Cohort 1, Sequence 1
50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 1, Sequence 2
50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 1, Sequence 3
Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 4
100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 5
100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 6
Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part B, Cohort 3, Sequence 1
100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
|
Part B, Cohort 3, Sequence 2
100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Washout Period From Second Intervention
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period From Second Intervention
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period From Third Intervention
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Fourth Intervention
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2940680 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A, Cohort 1, Sequence 1
n=4 Participants
50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study
|
Part A, Cohort 1, Sequence 2
n=2 Participants
50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 1, Sequence 3
n=2 Participants
Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 4
n=3 Participants
100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 5
n=3 Participants
100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part A, Cohort 2, Sequence 6
n=2 Participants
Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study.
|
Part B, Cohort 3, Sequence 1
n=7 Participants
100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
|
Part B, Cohort 3, Sequence 2
n=7 Participants
100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study.
|
Total
n=30 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
30 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 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
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)Population: All randomized participants.
Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=9 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=6 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=6 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=14 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
n=14 Participants
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
n=11 Participants
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
n=12 Participants
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
n=6 Participants
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
n=5 Participants
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Adverse Events (AEs)
|
2 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants in Part B of the study with evaluable Cmax data.
The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=14 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=14 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=11 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=10 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation
|
879 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.3
|
1170 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.4
|
776 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.3
|
1290 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
The Cmax of LY2940680 during Part A of the study was reported.
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=6 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=6 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=6 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=5 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)
|
622 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25.3
|
661 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 68.3
|
1740 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15.6
|
3360 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=6 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=6 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=6 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=5 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)
|
1.5 hours (h)
Interval 0.92 to 3.0
|
2 hours (h)
Interval 2.0 to 4.03
|
2 hours (h)
Interval 1.0 to 2.0
|
2 hours (h)
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study.
Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=14 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=14 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=11 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=10 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)
|
1 hours (h)
Interval 1.0 to 4.0
|
1.5 hours (h)
Interval 1.0 to 4.0
|
3 hours (h)
Interval 2.0 to 8.0
|
1 hours (h)
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration \[AUC(0-tlast)\]
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=6 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=6 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=6 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=5 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
|
5300 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27.5
|
9440 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 53.9
|
22800 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21.2
|
49300 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 who had evaluable PK data during Part B of the study.
Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration \[AUC(0-tlast)\]
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=14 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=14 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=11 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=10 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
|
9390 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 41.1
|
10300 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.9
|
11200 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37.2
|
9980 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity \[AUC(0-∞)\]
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=6 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=6 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=6 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=5 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]
|
5340 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27.4
|
9530 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 54.0
|
23000 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21.6
|
49800 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drugPopulation: Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study.
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity \[AUC(0-∞)\]
Outcome measures
| Measure |
Placebo Capsule (Fasted)
n=14 Participants
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=14 Participants
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A
n=11 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part B
n=10 Participants
100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet (Fasted)
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor(PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]
|
9460 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 41.3
|
10300 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40.1
|
11300 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37.3
|
10000 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50.1
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo Capsule (Fasted)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
50-mg LY2940680 Capsule (Fasted)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100-mg LY2940680 Capsule (Fasted) Part A or Part B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
100 mg LY2940680 Tablet (Fasted)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100-mg LY2940680 Tablet (Fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
200-mg LY2940680 Capsule (Fasted)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
400-mg LY2940680 Capsule (Fasted)
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 Capsule (Fasted)
n=9 participants at risk
Placebo capsule given once orally in fasted state during Part A of the study.
|
50-mg LY2940680 Capsule (Fasted)
n=6 participants at risk
50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
100-mg LY2940680 Capsule (Fasted) Part A or Part B
n=20 participants at risk
100-mg LY2940680 capsule administered once orally in fasted state during Part A or Part B of the study.
|
100 mg LY2940680 Tablet (Fasted)
n=14 participants at risk
100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study.
|
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)
n=11 participants at risk
100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole \[proton pump inhibitor (PPI)\] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study.
|
100-mg LY2940680 Tablet (Fed)
n=12 participants at risk
100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study.
|
200-mg LY2940680 Capsule (Fasted)
n=6 participants at risk
200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
400-mg LY2940680 Capsule (Fasted)
n=5 participants at risk
400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
0.00%
0/14
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9
|
0.00%
0/6
|
10.0%
2/20 • Number of events 3
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
|
General disorders
Facial pain
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
General disorders
Fatigue
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
|
General disorders
Feeling cold
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
General disorders
Pain
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Infections and infestations
Tooth infection
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
40.0%
2/5 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9
|
0.00%
0/6
|
15.0%
3/20 • Number of events 3
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
30.0%
6/20 • Number of events 6
|
21.4%
3/14 • Number of events 3
|
0.00%
0/11
|
25.0%
3/12 • Number of events 4
|
50.0%
3/6 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/8
|
0.00%
0/6
|
5.3%
1/19 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 1
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/20
|
7.1%
1/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 5
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9
|
0.00%
0/6
|
5.0%
1/20 • Number of events 5
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
|
Vascular disorders
Flushing
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/20
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60