Trial Outcomes & Findings for A Study of LY3127760 in Healthy Participants (NCT NCT01968070)
NCT ID: NCT01968070
Last Updated: 2019-06-07
Results Overview
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Baseline to Study Completion (Up To Day 42)
Results posted on
2019-06-07
Participant Flow
Part 1 was a single-ascending dose, 2-cohort, 3-period, alternating-group dose-escalation study (cohorts 1-2) and Part 2 of the study was a multiple-ascending dose, 4-cohort, parallel-group, dose-escalation study (cohorts 3-6). Replacement participants received interventions intended for those participants whom discontinued early.
Participant milestones
| Measure |
Cohort 1 Sequence 1
Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;
|
Cohort 1 Sequence 2
Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;
|
Cohort 1 Sequence 3
Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;
|
Cohort 2 Sequence 1
Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
|
Cohort 2 Sequence 2
Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;
|
Cohort 2 Sequence 3
Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
|
Cohort 3 LY3127760 60mg
Participants received 60mg LY3127760 capsules orally once daily.
|
Cohort 3 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 3 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 4 LY3127760 200mg
Participants received 200mg LY3127760 capsules orally once daily.
|
Cohort 4 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 4 Celcoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 5 LY3127760 20mg
Participants received 20mg LY3127760 capsules orally once daily.
|
Cohort 5 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 5 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 6 LY3127760 600mg
Participants received 300mg LY3127760 capsules orally twice daily.
|
Cohort 6 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 6 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
10
|
2
|
2
|
9
|
2
|
2
|
9
|
2
|
2
|
9
|
2
|
2
|
|
Period 1
COMPLETED
|
4
|
3
|
4
|
2
|
3
|
4
|
8
|
2
|
2
|
9
|
2
|
1
|
9
|
2
|
2
|
8
|
2
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 2
STARTED
|
4
|
4
|
4
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
4
|
4
|
4
|
4
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
4
|
4
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Sequence 1
Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;
|
Cohort 1 Sequence 2
Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;
|
Cohort 1 Sequence 3
Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;
|
Cohort 2 Sequence 1
Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
|
Cohort 2 Sequence 2
Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;
|
Cohort 2 Sequence 3
Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
|
Cohort 3 LY3127760 60mg
Participants received 60mg LY3127760 capsules orally once daily.
|
Cohort 3 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 3 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 4 LY3127760 200mg
Participants received 200mg LY3127760 capsules orally once daily.
|
Cohort 4 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 4 Celcoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 5 LY3127760 20mg
Participants received 20mg LY3127760 capsules orally once daily.
|
Cohort 5 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 5 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 6 LY3127760 600mg
Participants received 300mg LY3127760 capsules orally twice daily.
|
Cohort 6 Placebo
Participants received placebo capsules orally once daily.
|
Cohort 6 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 1
Protocol Violation
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3127760 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1 Sequence 1
n=4 Participants
Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;
|
Cohort 1 Sequence 2
n=5 Participants
Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;
|
Cohort 1 Sequence 3
n=4 Participants
Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;
|
Cohort 2 Sequence 1
n=6 Participants
Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
|
Cohort 2 Sequence 2
n=4 Participants
Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;
|
Cohort 2 Sequence 3
n=4 Participants
Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
|
Cohort 3 LY3127760 60mg
n=10 Participants
Participants received 60mg LY3127760 capsules orally once daily.
|
Cohort 3 Placebo
n=2 Participants
Participants received placebo capsules orally once daily.
|
Cohort 3 Celecoxib 400mg
n=2 Participants
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 4 LY3127760 200mg
n=9 Participants
Participants received 200mg LY3127760 capsules orally once daily.
|
Cohort 4 Placebo
n=2 Participants
Participants received placebo capsules orally once daily.
|
Cohort 4 Celcoxib 400mg
n=2 Participants
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 5 LY3127760 20mg
n=9 Participants
Participants received 20mg LY3127760 capsules orally once daily.
|
Cohort 5 Placebo
n=2 Participants
Participants received placebo capsules orally once daily.
|
Cohort 5 Celecoxib 400mg
n=2 Participants
Participants received 400mg Celecoxib capsules orally once daily.
|
Cohort 6 LY3127760 300mg
n=9 Participants
Participants received 300mg LY3127760 capsules orally twice daily.
|
Cohort 6 Placebo
n=2 Participants
Participants received placebo capsules orally once daily.
|
Cohort 6 Celecoxib 400mg
n=2 Participants
Participants received 400mg Celecoxib capsules orally once daily.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
9 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
80 Participants
n=667 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
9 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
58 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
9 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
80 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
28 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
47 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
4 participants
n=27 Participants
|
6 participants
n=483 Participants
|
4 participants
n=36 Participants
|
4 participants
n=10 Participants
|
10 participants
n=115 Participants
|
2 participants
n=40 Participants
|
2 participants
n=8 Participants
|
9 participants
n=62 Participants
|
2 participants
n=95 Participants
|
2 participants
n=129 Participants
|
9 participants
n=36 Participants
|
2 participants
n=36 Participants
|
2 participants
n=24 Participants
|
9 participants
n=135 Participants
|
2 participants
n=136 Participants
|
2 participants
n=44 Participants
|
80 participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (Up To Day 42)Population: All randomized participants who received at least one dose of study drug.
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Part 1: Placebo
n=19 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=8 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=8 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
n=8 Participants
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
n=8 Participants
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
n=8 Participants
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
n=8 Participants
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
n=9 Participants
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
n=10 Participants
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
n=9 Participants
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
n=9 Participants
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
n=8 Participants
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 HoursPopulation: All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable AUC data.
Outcome measures
| Measure |
Part 1: Placebo
n=8 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=6 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=6 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
n=8 Participants
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
n=6 Participants
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
Celecoxib administered PO, QD, for 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
|
NA nanograms•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
Not calculated because multiple concentrations were below the detection limit of the assay
|
3010 nanograms•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 42
|
17200 nanograms•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 9
|
40000 nanograms•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 17
|
47400 nanograms•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 20
|
71900 nanograms•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 HoursPopulation: All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Cmax data.
Outcome measures
| Measure |
Part 1: Placebo
n=8 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=8 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=8 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
n=8 Participants
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
n=8 Participants
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
Celecoxib administered PO, QD, for 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760
|
264 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
890 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
3880 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
10300 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
18900 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
21600 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 HoursPopulation: All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Tmax data.
Outcome measures
| Measure |
Part 1: Placebo
n=8 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=8 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=8 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
n=8 Participants
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
n=8 Participants
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
Celecoxib administered PO, QD, for 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760
|
2.00 Hour
Interval 1.0 to 4.0
|
2.00 Hour
Interval 1.0 to 4.02
|
2.00 Hour
Interval 0.25 to 4.0
|
2.00 Hour
Interval 2.0 to 4.0
|
1.00 Hour
Interval 0.52 to 2.0
|
1.50 Hour
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 HoursPopulation: All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable AUC data.
AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.
Outcome measures
| Measure |
Part 1: Placebo
n=9 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=8 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=9 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
Celecoxib administered PO, QD, for 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760
|
1020 ng•hr/ml
Geometric Coefficient of Variation 20
|
4350 ng•hr/ml
Geometric Coefficient of Variation 50
|
11300 ng•hr/ml
Geometric Coefficient of Variation 23
|
19700 ng•hr/ml
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 HoursPopulation: All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Cmax data.
Outcome measures
| Measure |
Part 1: Placebo
n=9 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=8 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=9 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
Celecoxib administered PO, QD, for 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Cmax of Multiple Doses LY3127760
|
301 ng/mL
Geometric Coefficient of Variation 19
|
1210 ng/mL
Geometric Coefficient of Variation 53
|
3650 ng/mL
Geometric Coefficient of Variation 27
|
6170 ng/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 HoursPopulation: All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Tmax data.
Outcome measures
| Measure |
Part 1: Placebo
n=9 Participants
Placebo, Single Dose Administered PO
|
Part 1: 20 mg LY3127760
n=8 Participants
20 mg LY3127760 Single Dose Administered PO
|
Part 1: 60 mg LY3127760
n=9 Participants
60 mg LY3127760 Single Dose Administered PO
|
Part 1: 200 mg LY3127760
n=8 Participants
200 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760
600 mg LY3127760 Single Dose Administered PO
|
Part 1: 600 mg LY3127760 (Fasted)
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
|
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
|
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.
|
Part 2: 300 mg LY3127760
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
|
Part 2: 400 mg Celecoxib
Celecoxib administered PO, QD, for 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Tmax of Multiple Doses LY3127760
|
2.00 hour
Interval 1.0 to 4.0
|
1.65 hour
Interval 1.0 to 4.0
|
2.00 hour
Interval 1.0 to 2.02
|
2.00 hour
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (Part 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
20 mg LY3127760 (Part 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
60 mg LY3127760 (Part 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200 mg LY3127760 (Part 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
600 mg LY3127760 (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
600 mg LY3127760 (Fasted) (Part 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
900 mg LY3127760 (Part 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Part 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
20 mg LY3127760 (Part 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
60 mg LY3127760 (Part 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
200 mg LY3127760 (Part 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
300 mg LY3127760 (Part 2)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
400 mg Celecoxib (Part 2)
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 (Part 1)
n=19 participants at risk
Placebo, Single Dose Administered PO
|
20 mg LY3127760 (Part 1)
n=8 participants at risk
20 mg LY3127760 Single Dose Administered PO
|
60 mg LY3127760 (Part 1)
n=8 participants at risk
60 mg LY3127760 Single Dose Administered PO
|
200 mg LY3127760 (Part 1)
n=8 participants at risk
200 mg LY3127760 Single Dose Administered PO
|
600 mg LY3127760 (Part 1)
n=8 participants at risk
600 mg LY3127760 Single Dose Administered PO
|
600 mg LY3127760 (Fasted) (Part 1)
n=8 participants at risk
600 mg LY3127760 Single Dose Administered PO During Fasted State
|
900 mg LY3127760 (Part 1)
n=8 participants at risk
900 mg LY3127760 Single Dose Administered PO
|
Placebo (Part 2)
n=8 participants at risk
Placebo, Administered QD PO, Day 1-28
|
20 mg LY3127760 (Part 2)
n=9 participants at risk
20 mg LY3127760 Administered QD PO, Day 1-28
|
60 mg LY3127760 (Part 2)
n=10 participants at risk
60 mg LY3127760 Administered QD PO, Day 1-28
|
200 mg LY3127760 (Part 2)
n=9 participants at risk
200 mg LY3127760 Administered QD PO, Day 1-28
|
300 mg LY3127760 (Part 2)
n=9 participants at risk
300 mg LY3127760 Administered BID PO, Day 1-28
|
400 mg Celecoxib (Part 2)
n=8 participants at risk
400 mg celecoxib Administered QD PO, Day 1-28
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
22.2%
2/9 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
22.2%
2/9 • Number of events 3
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
20.0%
2/10 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
20.0%
2/10 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
General disorders
Chills
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
General disorders
Pain
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Infections and infestations
Otitis media
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
10.0%
1/10 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
20.0%
2/10 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
20.0%
2/10 • Number of events 4
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
25.0%
2/8 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.5%
2/19 • Number of events 2
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
11.1%
1/9 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
|
Vascular disorders
Flushing
|
0.00%
0/19
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
12.5%
1/8 • Number of events 1
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/10
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/9
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
0.00%
0/8
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
|
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