Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01 (NCT NCT02377362)
NCT ID: NCT02377362
Last Updated: 2019-03-21
Results Overview
Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
Baseline to 7 weeks
Results posted on
2019-03-21
Participant Flow
Part A was a 3-period crossover design. Part A participants were to receive 2 escalating single doses of study drug and one dose of placebo. Part B participants were randomized to multiple doses of study drug or placebo. The study was stopped after Part B.
Participant milestones
| Measure |
GLWL-01, Part A (Placebo; 150 mg; 600 mg)
Part A: Cohort 1(C1) Sequence 1 (Placebo, 150 mg, 600 mg)
Placebo was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention.
|
GLWL-01, Part A (10 mg; Placebo; 600 mg)
Part A: Cohort 1(C1) Sequence 2 (10 mg, Placebo, 600 mg)
10 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention.
|
GLWL-01, Part A (10 mg; 150 mg; Placebo)
Part A: Cohort 1(C1) Sequence 3 (10 mg, 150 mg, Placebo)
10 mg GLWL 01 was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention.
|
GLWL-01, Part A (Placebo; 300 mg; 1200 mg)
Part A: Cohort 2(C2) Sequence 1 (Placebo, 300 mg, 1200 mg)
Placebo was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention
|
GLWL-01, Part A (50 mg, Placebo; 1200 mg)
Part A: Cohort 2(C2) Sequence 2 (50 mg, Placebo, 1200 mg)
50 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention
|
GLWL-01, Part A ( 50 mg; 300 mg; Placebo)
Part A: Cohort 2(C3) Sequence 3 (50 mg, 300 mg, Placebo)
50 mg GLWL 01 was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention.
|
GLWL-01, Part B (50 mg, Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (150 mg Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (300 mg Once a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (450 mg Once a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B, (450 mg Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (600 mg Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
Placebo, Part B
Multiple oral doses of placebo to match GLWL-01
Placebo, Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A First Treatment
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A First Treatment
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A First Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Second Treatment
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Second Treatment
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Second Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Third Treatment
STARTED
|
4
|
4
|
4
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Third Treatment
COMPLETED
|
4
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Third Treatment
NOT COMPLETED
|
0
|
0
|
0
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B Overall
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
6
|
7
|
6
|
7
|
12
|
|
Part B Overall
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
5
|
6
|
6
|
6
|
6
|
12
|
|
Part B Overall
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
GLWL-01, Part A (Placebo; 150 mg; 600 mg)
Part A: Cohort 1(C1) Sequence 1 (Placebo, 150 mg, 600 mg)
Placebo was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention.
|
GLWL-01, Part A (10 mg; Placebo; 600 mg)
Part A: Cohort 1(C1) Sequence 2 (10 mg, Placebo, 600 mg)
10 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention.
|
GLWL-01, Part A (10 mg; 150 mg; Placebo)
Part A: Cohort 1(C1) Sequence 3 (10 mg, 150 mg, Placebo)
10 mg GLWL 01 was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention.
|
GLWL-01, Part A (Placebo; 300 mg; 1200 mg)
Part A: Cohort 2(C2) Sequence 1 (Placebo, 300 mg, 1200 mg)
Placebo was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention
|
GLWL-01, Part A (50 mg, Placebo; 1200 mg)
Part A: Cohort 2(C2) Sequence 2 (50 mg, Placebo, 1200 mg)
50 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention
|
GLWL-01, Part A ( 50 mg; 300 mg; Placebo)
Part A: Cohort 2(C3) Sequence 3 (50 mg, 300 mg, Placebo)
50 mg GLWL 01 was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention.
|
GLWL-01, Part B (50 mg, Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (150 mg Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (300 mg Once a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (450 mg Once a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B, (450 mg Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (600 mg Twice a Day)
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
Placebo, Part B
Multiple oral doses of placebo to match GLWL-01
Placebo, Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Second Treatment
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Third Treatment
Highest dose level 1200 not used
|
0
|
0
|
0
|
4
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B Overall
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part B Overall
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B Overall
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01
Baseline characteristics by cohort
| Measure |
GLWL-01, Part A (Placebo; 150 mg; 600 mg)
n=4 Participants
Part A: Cohort 1(C1) Sequence 1 (Placebo, 150 mg, 600 mg)
Placebo was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention
|
GLWL-01, Part A (10 mg; Placebo; 600 mg)
n=4 Participants
Part A: Cohort 1(C1) Sequence 2 (10 mg, Placebo, 600 mg)
10 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 600 mg GLWL 01 was taken orally third intervention.
|
GLWL-01, Part A (10 mg; 150 mg; Placebo)
n=4 Participants
Part A: Cohort 1(C1) Sequence 3 (10 mg, 150 mg, Placebo)
10 mg GLWL 01 was taken orally first intervention, then 150 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention
|
GLWL-01, Part A (Placebo; 300 mg; 1200 mg)
n=4 Participants
Part A: Cohort 2(C2) Sequence 1 (Placebo, 300 mg, 1200 mg)
Placebo was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention
|
GLWL-01 Part A (50 mg, Placebo; 1200 mg)
n=4 Participants
Part A: Cohort 2(C2) Sequence 2 (50 mg, Placebo, 1200 mg)
50 mg GLWL 01 was taken orally first intervention, then Placebo was taken orally second intervention, then 1200 mg GLWL 01 was taken orally third intervention
|
GLWL-01, Part A ( 50 mg; 300 mg; Placebo)
n=4 Participants
Part A: Cohort 2(C3) Sequence 3 (50 mg, 300 mg, Placebo)
50 mg GLWL 01 was taken orally first intervention, then 300 mg GLWL 01 was taken orally second intervention, then Placebo was taken orally third intervention
|
GLWL-01, Part B (50 mg Twice a Day)
n=6 Participants
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (150 mg Twice a Day)
n=6 Participants
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (300 mg Once a Day)
n=6 Participants
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (450 mg Once a Day)
n=7 Participants
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (450 mg Twice a Day)
n=6 Participants
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
GLWL-01, Part B (600 mg Twice a Day)
n=7 Participants
Multiple oral doses
Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
Placebo, Part B
n=12 Participants
Multiple daily doses of placebo to match GLWL-01
Placebo, Part B: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
66 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
27 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
47 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
56 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
66 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
74 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 weeksTreatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
n=19 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Treatment Emergent Adverse Events (Part A)
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksTreatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=6 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=6 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=7 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=7 Participants
|
GLWL-01 Part B Placebo
n=12 Participants
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Treatment Emergent Adverse Events (Parts B)
|
5 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part A)
|
0.5119 µg*hr/mL
Geometric Coefficient of Variation 15.7
|
3.138 µg*hr/mL
Geometric Coefficient of Variation 13.7
|
12.91 µg*hr/mL
Geometric Coefficient of Variation 38.2
|
35.16 µg*hr/mL
Geometric Coefficient of Variation 16.9
|
118.8 µg*hr/mL
Geometric Coefficient of Variation 32.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part B)
|
5040 ng*hr/mL
Geometric Coefficient of Variation 30.6
|
37000 ng*hr/mL
Geometric Coefficient of Variation 22.5
|
47500 ng*hr/mL
Geometric Coefficient of Variation 17.1
|
124000 ng*hr/mL
Geometric Coefficient of Variation 41.9
|
202000 ng*hr/mL
Geometric Coefficient of Variation 26.6
|
235000 ng*hr/mL
Geometric Coefficient of Variation 39.2
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Part A)
|
0.551 µg*hr/mL
Geometric Coefficient of Variation 16.5
|
3.15 µg*hr/mL
Geometric Coefficient of Variation 11.6
|
12.6 µg*hr/mL
Geometric Coefficient of Variation 38.0
|
34.4 µg*hr/mL
Geometric Coefficient of Variation 16.9
|
110 µg*hr/mL
Geometric Coefficient of Variation 29.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Parts B)
|
5040 ng*hr/mL
Geometric Coefficient of Variation 30.6
|
34600 ng*hr/mL
Geometric Coefficient of Variation 21.7
|
45700 ng*hr/mL
Geometric Coefficient of Variation 16.9
|
111000 ng*hr/mL
Geometric Coefficient of Variation 39.0
|
184000 ng*hr/mL
Geometric Coefficient of Variation 25.2
|
210000 ng*hr/mL
Geometric Coefficient of Variation 37.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part A)
|
0.555 µg*hr/mL
Geometric Coefficient of Variation 16.7
|
3.19 µg*hr/mL
Geometric Coefficient of Variation 12.1
|
13.0 µg*hr/mL
Geometric Coefficient of Variation 41.2
|
35.4 µg*hr/mL
Geometric Coefficient of Variation 17.5
|
119 µg*hr/mL
Geometric Coefficient of Variation 32.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting Day 1Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=6 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=6 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=7 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=7 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part B)
|
3150 ng*hr/mL
Geometric Coefficient of Variation 20.1
|
13500 ng*hr/mL
Geometric Coefficient of Variation 14.8
|
31800 ng*hr/mL
Geometric Coefficient of Variation 21.9
|
69300 ng*hr/mL
Geometric Coefficient of Variation 31.4
|
79000 ng*hr/mL
Geometric Coefficient of Variation 19.5
|
127000 ng*hr/mL
Geometric Coefficient of Variation 16.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) (Part A)
|
0.121 µg/mL
Geometric Coefficient of Variation 8.4
|
0.600 µg/mL
Geometric Coefficient of Variation 35.4
|
2.47 µg/mL
Geometric Coefficient of Variation 39.9
|
5.08 µg/mL
Geometric Coefficient of Variation 17.6
|
11.5 µg/mL
Geometric Coefficient of Variation 23.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) (Part B)
|
785 ng/mL
Geometric Coefficient of Variation 45.8
|
37.90 ng/mL
Geometric Coefficient of Variation 28.1
|
62.80 ng/mL
Geometric Coefficient of Variation 10.6
|
10800 ng/mL
Geometric Coefficient of Variation 31.5
|
16300 ng/mL
Geometric Coefficient of Variation 25.9
|
18200 ng/mL
Geometric Coefficient of Variation 33.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Time to Observed Cmax (Tmax) (Part A)
|
1.00 hours
Interval 0.999 to 1.02
|
1.51 hours
Interval 0.476 to 4.5
|
1.02 hours
Interval 0.466 to 4.55
|
1.50 hours
Interval 1.0 to 4.5
|
1.00 hours
Interval 0.998 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Time to Observed Cmax (Tmax) (Part B)
|
2.00 hours
Interval 1.0 to 4.5
|
2.00 hours
Interval 2.0 to 4.5
|
1.00 hours
Interval 0.99 to 2.0
|
3.25 hours
Interval 0.999 to 6.0
|
2.00 hours
Interval 1.0 to 4.5
|
4.5 hours
Interval 2.0 to 4.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Elimination Half-Life (T1/2) (Part A)
|
3.32 hours
Geometric Coefficient of Variation 8.8
|
3.77 hours
Geometric Coefficient of Variation 23.9
|
5.22 hours
Geometric Coefficient of Variation 25.3
|
5.25 hours
Geometric Coefficient of Variation 25.8
|
5.47 hours
Geometric Coefficient of Variation 19.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Elimination Half-Life (T1/2) (Part B)
|
5.33 hours
Geometric Coefficient of Variation 12.1
|
6.16 hours
Geometric Coefficient of Variation 15.16
|
5.24 hours
Geometric Coefficient of Variation 20.3
|
5.94 hours
Geometric Coefficient of Variation 14.9
|
5.12 hours
Geometric Coefficient of Variation 18.5
|
6.26 hours
Geometric Coefficient of Variation 16.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Apparent Clearance of Drug (CL/F) (Part A)
|
18.27 L/hr
Standard Deviation 3.17
|
15.78 L/hr
Standard Deviation 2.18
|
12.16 L/hr
Standard Deviation 4.16
|
8.59 L/hr
Standard Deviation 1.37
|
5.27 L/hr
Standard Deviation 1.77
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Apparent Clearance of Drug (CL/F) (Part B)
|
11.4 L/hr
Standard Deviation 3.57
|
5.20 L/hr
Standard Deviation 1.14
|
6.64 L/hr
Standard Deviation 1.10
|
4.27 L/hr
Standard Deviation 1.35
|
3.23 L/hr
Standard Deviation 0.76
|
3.97 L/hr
Standard Deviation 1.36
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-doseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=8 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Apparent Total Volume of Distribution (VZ/F) (Part A)
|
86.87 L
Standard Deviation 10.765
|
86.35 L
Standard Deviation 15.326
|
88.09 L
Standard Deviation 17.282
|
66.97 L
Standard Deviation 20.368
|
41.43 L
Standard Deviation 13.114
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Apparent Total Volume of Distribution (VZ/F) (Part B)
|
89.6 L
Standard Deviation 39.15
|
46.3 L
Standard Deviation 10.18
|
51.2 L
Standard Deviation 14.76
|
36.8 L
Standard Deviation 12.39
|
24.2 L
Standard Deviation 7.055
|
35.8 L
Standard Deviation 12.01
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose and 12 hours Post-DosePopulation: Data were not collected
Data Not Collected for this Parameter
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-Dose and 12 hours Post-Dose on Day 28Population: Data were not collected
Data Not Collected for this Parameter
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-Dose and 24-hours Post-DoseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=7 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Amount of Drug Excreted in Urine (Aet0-24) (Part A)
|
1.87 mg
Standard Deviation 0.611
|
11.7 mg
Standard Deviation 2.56
|
36.9 mg
Standard Deviation 12.1
|
101 mg
Standard Deviation 15.2
|
191 mg
Standard Deviation 37.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose and 24-hours Post-Dose on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Amount of Drug Excreted in Urine (Aet0-24) (Part B)
|
28.2 mg
Standard Deviation 12.87
|
94.8 mg
Standard Deviation 9.843
|
125 mg
Standard Deviation 33.45
|
175 mg
Standard Deviation 25.93
|
272 mg
Standard Deviation 67.08
|
293 mg
Standard Deviation 77.33
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose and 24-hours Post-DoseOutcome measures
| Measure |
GLWL-01 Part A (10mg)
n=7 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=8 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=8 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=8 Participants
600 mg
|
GLWL-01 Part A Placebo
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Fraction of Drug Excreted in the Urine (Fe) (Part A)
|
18.7 percentage of the drug
Standard Deviation 6.11
|
23.3 percentage of the drug
Standard Deviation 5.13
|
24.6 percentage of the drug
Standard Deviation 8.08
|
33.6 percentage of the drug
Standard Deviation 5.07
|
31.8 percentage of the drug
Standard Deviation 6.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose and 24-hours Post-Dose on Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
|
|---|---|---|---|---|---|---|---|
|
Fraction of Drug Excreted in the Urine (Fe) (Part B)
|
56.3 percentage of the drug
Standard Deviation 25.74
|
63.2 percentage of the drug
Standard Deviation 6.562
|
41.5 percentage of the drug
Standard Deviation 11.15
|
38.9 percentage of the drug
Standard Deviation 5.761
|
60.5 percentage of the drug
Standard Deviation 14.91
|
48.9 percentage of the drug
Standard Deviation 12.89
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 24-26Population: The 450 mg twice a day arm had no usable continuous glucose data, due to technical difficulties
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=5 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=4 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=4 Participants
300 mg
|
GLWL-01 Part A (600 mg)
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=9 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Plasma Glucose Concentration After Multiple Doses (Part B)
|
22.53 mg/dL
Standard Deviation 23.0
|
7.38 mg/dL
Standard Deviation 40.4
|
7.92 mg/dL
Standard Deviation 30.3
|
21.39 mg/dL
Standard Deviation 13.5
|
—
|
5.43 mg/dL
Standard Deviation 38.0
|
8.05 mg/dL
Standard Deviation 41.9
|
SECONDARY outcome
Timeframe: Day 28Mixed Meal Tolerance Test (4.5 hours after a meal on Day 28); Baseline Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=12 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Postprandial Glucose (Part B)
|
18.8 mg/dL
Standard Deviation 11.70
|
11.6 mg/dL
Standard Deviation 27.74
|
-13.7 mg/dL
Standard Deviation 33.16
|
10.7 mg/dL
Standard Deviation 27.40
|
29.3 mg/dL
Standard Deviation 49.43
|
29.7 mg/dL
Standard Deviation 25.77
|
13.2 mg/dL
Standard Deviation 41.41
|
SECONDARY outcome
Timeframe: Day 28Mixed Meal Tolerance Test (4.5 hours after a meal on Day 28); Baseline-Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=3 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=11 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Peptide Concentration (Part B)
|
0.373 ng/mL
Standard Deviation 0.257
|
0.338 ng/mL
Standard Deviation 0.9523
|
0.437 ng/mL
Standard Deviation 0.5171
|
0.575 ng/mL
Standard Deviation 1.0658
|
0.360 ng/mL
Standard Deviation 1.3600
|
0.457 ng/mL
Standard Deviation 0.8498
|
0.043 ng/mL
Standard Deviation 0.6513
|
SECONDARY outcome
Timeframe: Day 284.5 hours following Mixed Meal Tolerance Test (MMTT) on Day 28; Baseline Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=3 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=11 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin Concentration (Part B)
|
-3.60 uU/mL
Standard Deviation 7.579
|
-3.89 uU/mL
Standard Deviation 11.533
|
-9.75 uU/mL
Standard Deviation 10.687
|
2.12 uU/mL
Standard Deviation 5.878
|
1.27 uU/mL
Standard Deviation 9.194
|
0.23 uU/mL
Standard Deviation 7.653
|
2.39 uU/mL
Standard Deviation 8.263
|
SECONDARY outcome
Timeframe: Baseline to Day 28Fasting glucose concentration after 28 day treatment
Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=3 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=4 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=10 Participants
|
|---|---|---|---|---|---|---|---|
|
Fasting Glucose Concentration (Part B)
|
1.15 mmol/L
Standard Deviation 1.139
|
1.10 mmol/L
Standard Deviation 1.520
|
-0.20 mmol/L
Standard Deviation 2.100
|
0.63 mmol/L
Standard Deviation 0.299
|
-1.13 mmol/L
Standard Deviation 1.381
|
-0.10 mmol/L
Standard Deviation 2.104
|
0.91 mmol/L
Standard Deviation 2.116
|
SECONDARY outcome
Timeframe: Baseline to Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=12 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weight (Part B)
|
-0.375 kilograms (kg)
Standard Deviation 0.763
|
-0.340 kilograms (kg)
Standard Deviation 0.786
|
-0.150 kilograms (kg)
Standard Deviation 0.995
|
-0.417 kilograms (kg)
Standard Deviation 0.741
|
0.417 kilograms (kg)
Standard Deviation 1.229
|
0.350 kilograms (kg)
Standard Deviation 0.356
|
-0.025 kilograms (kg)
Standard Deviation 0.717
|
SECONDARY outcome
Timeframe: Baseline to Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=12 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference (Part B)
|
-1.275 centimeters
Standard Deviation 3.522
|
1.360 centimeters
Standard Deviation 5.755
|
-3.517 centimeters
Standard Deviation 4.001
|
-1.383 centimeters
Standard Deviation 5.123
|
-1.250 centimeters
Standard Deviation 1.091
|
-0.083 centimeters
Standard Deviation 0.492
|
-0.867 centimeters
Standard Deviation 4.026
|
SECONDARY outcome
Timeframe: Baseline to Day 28Outcome measures
| Measure |
GLWL-01 Part A (10mg)
n=4 Participants
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=5 Participants
50 mg
|
GLWL-01 Part A (150 mg)
n=6 Participants
150 mg
|
GLWL-01 Part A (300 mg)
n=6 Participants
300 mg
|
GLWL-01 Part A (600 mg)
n=6 Participants
600 mg
|
GLWL-01 Part A Placebo
n=6 Participants
|
GLWL-01 Part B Placebo
n=12 Participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hip Circumference (Part B)
|
-1.05 centimeters
Standard Deviation 2.940
|
0.960 centimeters
Standard Deviation 7.442
|
1.283 centimeters
Standard Deviation 2.337
|
-0.417 centimeters
Standard Deviation 2.094
|
0.167 centimeters
Standard Deviation 0.753
|
-0.333 centimeters
Standard Deviation 0.516
|
0.192 centimeters
Standard Deviation 6.860
|
Adverse Events
GLWL-01, Part A (10mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GLWL-01 Part A (50 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GLWL-01 Part A (150 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GLWL-01 Part A (300 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GLWL-01 Part A (600 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GLWL-01 Part A Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GLWL-01 Part B (50 mg, Twice a Day)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GLWL-01 Part B (150 mg, Twice a Day)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GLWL-01 Part B (300 mg, Once a Day)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GLWL-01 Part B (450 mg, Once a Day)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GLWL-01 Part B (450 mg, Twice a Day)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GLWL-01 Part B (600 mg, Twice a Day)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GLWL-01 Part B Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GLWL-01, Part A (10mg)
n=8 participants at risk
10 milligrams (mg)
|
GLWL-01 Part A (50 mg)
n=8 participants at risk
50 mg
|
GLWL-01 Part A (150 mg)
n=8 participants at risk
150 mg
|
GLWL-01 Part A (300 mg)
n=8 participants at risk
300 mg
|
GLWL-01 Part A (600 mg)
n=8 participants at risk
600 mg
|
GLWL-01 Part A Placebo
n=19 participants at risk
|
GLWL-01 Part B (50 mg, Twice a Day)
n=6 participants at risk
|
GLWL-01 Part B (150 mg, Twice a Day)
n=6 participants at risk
|
GLWL-01 Part B (300 mg, Once a Day)
n=6 participants at risk
|
GLWL-01 Part B (450 mg, Once a Day)
n=7 participants at risk
|
GLWL-01 Part B (450 mg, Twice a Day)
n=6 participants at risk
|
GLWL-01 Part B (600 mg, Twice a Day)
n=7 participants at risk
|
GLWL-01 Part B Placebo
n=12 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
33.3%
2/6 • Number of events 4
|
16.7%
1/6 • Number of events 6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
33.3%
4/12 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
33.3%
2/6 • Number of events 5
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
28.6%
2/7 • Number of events 3
|
0.00%
0/6
|
57.1%
4/7 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
10.5%
2/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Catheter site pain
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Catheter site paraesthesia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
57.1%
4/7 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Vascular disorders
Pallor
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Eye disorders
Visual impairment
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Faeces Discolored
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Fatigue
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Medical Device Site Haemorrhage
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Oedema Peripheral Pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Vessel Puncture Site Induration
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
|
Infections and infestations
Otitis Media
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood Glucose Increase
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood Creatine Phosphokinase Increase
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Eye disorders
Eye Irritation
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar Erythema
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
General disorders
Pain
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place