Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers (NCT NCT01681277)
NCT ID: NCT01681277
Last Updated: 2017-01-20
Results Overview
Percentage of participants with drug-related adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From administration of study drug until end-of-study, up to 17 days
Results posted on
2017-01-20
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
n=9 Participants
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.9 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
40.9 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
44.2 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
43.8 Years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
40.1 Years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
41.9 Years
STANDARD_DEVIATION 6.5 • n=8 Participants
|
|
Gender
Female
|
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
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From administration of study drug until end-of-study, up to 17 daysPopulation: Treated set
Percentage of participants with drug-related adverse events
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
n=9 Participants
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events
|
33.3 percentage of participants
|
33.3 percentage of participants
|
22.2 percentage of participants
|
88.9 percentage of participants
|
77.8 percentage of participants
|
PRIMARY outcome
Timeframe: From administration of study drug until end-of-study, up to 17 daysPopulation: Treated Set (TS)
Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
n=9 Participants
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.Population: PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Cmax,ss
|
119 nmol/L
Geometric Coefficient of Variation 58.2
|
261 nmol/L
Geometric Coefficient of Variation 40.3
|
648 nmol/L
Geometric Coefficient of Variation 27.7
|
549 nmol/L
Geometric Coefficient of Variation 41.7
|
—
|
SECONDARY outcome
Timeframe: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.Population: PKS
Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Tmax,ss
|
0.500 h
Interval 0.25 to 0.5
|
0.500 h
Interval 0.25 to 2.0
|
0.750 h
Interval 0.5 to 1.0
|
0.750 h
Interval 0.25 to 4.0
|
—
|
SECONDARY outcome
Timeframe: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.Population: PKS
Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
AUCtau,ss
|
491 nmol*h/L
Geometric Coefficient of Variation 48.5
|
1290 nmol*h/L
Geometric Coefficient of Variation 29.0
|
3030 nmol*h/L
Geometric Coefficient of Variation 32.2
|
2290 nmol*h/L
Geometric Coefficient of Variation 20.0
|
—
|
SECONDARY outcome
Timeframe: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.Population: PKS
Terminal half-life of the analyte in plasma at steady state (t1/2,ss).
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
t1/2,ss
|
14.0 h
Geometric Coefficient of Variation 15.4
|
12.9 h
Geometric Coefficient of Variation 22.8
|
12.9 h
Geometric Coefficient of Variation 14.7
|
13.1 h
Geometric Coefficient of Variation 15.6
|
—
|
SECONDARY outcome
Timeframe: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.Population: PKS
Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
RA,Cmax
|
1.36 Ratio
Geometric Coefficient of Variation 54.0
|
1.15 Ratio
Geometric Coefficient of Variation 23.6
|
1.09 Ratio
Geometric Coefficient of Variation 34.3
|
0.915 Ratio
Geometric Coefficient of Variation 38.8
|
—
|
SECONDARY outcome
Timeframe: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.Population: PKS
Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 Participants
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 Participants
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 Participants
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
RA,AUC
|
1.29 Ratio
Geometric Coefficient of Variation 29.9
|
1.48 Ratio
Geometric Coefficient of Variation 13.0
|
1.37 Ratio
Geometric Coefficient of Variation 14.5
|
1.05 Ratio
Geometric Coefficient of Variation 15.6
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 113608 25 mg Bid (DG1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 113608 50 mg Bid (DG2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 113608 100 mg Bid (DG3)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 113608 100 mg qd (DG4)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
|
BI 113608 25 mg Bid (DG1)
n=9 participants at risk
Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 50 mg Bid (DG2)
n=9 participants at risk
DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg Bid (DG3)
n=9 participants at risk
DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
|
BI 113608 100 mg qd (DG4)
n=9 participants at risk
DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Infections and infestations
Folliculitis
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
88.9%
8/9 • From administration of study drug until end-of-study, up to 17 days
|
22.2%
2/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
22.2%
2/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Nervous system disorders
Facial paresis
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Eye disorders
Lacrimation increased
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
33.3%
3/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
22.2%
2/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
55.6%
5/9 • From administration of study drug until end-of-study, up to 17 days
|
22.2%
2/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
22.2%
2/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
55.6%
5/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
33.3%
3/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
22.2%
2/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
General disorders
Fatigue
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
General disorders
Feeling of relaxation
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
General disorders
Sensation of pressure
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
General disorders
Spinal pain
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
General disorders
Thirst
|
8.3%
1/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Investigations
Body temperature increased
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/12 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
0.00%
0/9 • From administration of study drug until end-of-study, up to 17 days
|
11.1%
1/9 • From administration of study drug until end-of-study, up to 17 days
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER