Trial Outcomes & Findings for Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers (NCT NCT01347086)
NCT ID: NCT01347086
Last Updated: 2016-04-15
Results Overview
Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint. The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.
Results posted on
2016-04-15
Participant Flow
60 subjects were included (27 Chinese, 25 Japanese, and 8 Caucasian subjects). 24 Japanese and 24 Chinese subjects were randomised to 1 of 3 (rising) dose groups and received single oral doses of either 400mg, 800mg, or 1200mg of BI 207127 NA or of the respective placebo. Caucasian subjects were randomised to 1200 mg BI 207127 NA or placebo.
The decision to proceed to the next higher dose group was based upon the safety of the preceding dose group. Caucasian subjects were randomised to receive either placebo or 1200 mg BI 207127 NA; this dose group could be started independently from the results of dose escalation in the Asian subjects.
Participant milestones
| Measure |
Placebo (Caucasian Subjects)
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Caucasian Subjects)
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
7
|
6
|
6
|
6
|
7
|
7
|
6
|
7
|
|
Overall Study
COMPLETED
|
2
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Caucasian Subjects)
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Caucasian Subjects)
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
failed screening visit
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers
Baseline characteristics by cohort
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=2 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
n=6 Participants
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
23.7 years
STANDARD_DEVIATION 3.6 • n=21 Participants
|
29.2 years
STANDARD_DEVIATION 7.1 • n=10 Participants
|
24.7 years
STANDARD_DEVIATION 2.1 • n=115 Participants
|
26.0 years
STANDARD_DEVIATION 3.9 • n=24 Participants
|
23.7 years
STANDARD_DEVIATION 2.3 • n=42 Participants
|
23.0 years
STANDARD_DEVIATION 2.1 • n=42 Participants
|
26.4 years
STANDARD_DEVIATION 5.2 • n=42 Participants
|
|
Sex: Female, Male
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.Population: Treated set (full analysis set according to the International Conference on Harmonization (ICH) E9 guideline): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint. The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history.
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=2 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
n=6 Participants
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug Related Adverse Events
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.Population: The treated set.
Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint. New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=2 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
n=6 Participants
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administrationPopulation: The pharmacokinetic (PK) analysis set: all evaluable subjects of the treated set who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.
Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-∞ of Deleobuvir
|
61.2 µmol*h/L
Geometric Coefficient of Variation 45.5
|
14.0 µmol*h/L
Geometric Coefficient of Variation 56.1
|
31.4 µmol*h/L
Geometric Coefficient of Variation 52.3
|
48.2 µmol*h/L
Geometric Coefficient of Variation 39.1
|
8.7 µmol*h/L
Geometric Coefficient of Variation 78.7
|
42.6 µmol*h/L
Geometric Coefficient of Variation 28.2
|
72.0 µmol*h/L
Geometric Coefficient of Variation 55.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Deleobuvir
|
6.01 h
Interval 5.0 to 8.0
|
4.51 h
Interval 4.0 to 6.02
|
5.50 h
Interval 4.0 to 6.0
|
5.00 h
Interval 4.0 to 6.0
|
4.50 h
Interval 2.5 to 5.0
|
5.00 h
Interval 4.0 to 6.0
|
5.50 h
Interval 4.0 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Maximum measured concentration of the analyte in plasma (Deleobuvir).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Deleobuvir
|
11.8 µmol/L
Geometric Coefficient of Variation 42.0
|
3.2 µmol/L
Geometric Coefficient of Variation 63.9
|
6.41 µmol/L
Geometric Coefficient of Variation 47.4
|
8.26 µmol/L
Geometric Coefficient of Variation 37.7
|
2.32 µmol/L
Geometric Coefficient of Variation 75.5
|
8.89 µmol/L
Geometric Coefficient of Variation 24.1
|
12.9 µmol/L
Geometric Coefficient of Variation 51.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 400mg", "Japanese 800mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞.
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=5 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)
|
12.7 µmol*h/L
Geometric Coefficient of Variation 54.6
|
10.1 µmol*h/L
Geometric Coefficient of Variation 54.2
|
5.97 µmol*h/L
Geometric Coefficient of Variation 23.9
|
9.01 µmol*h/L
Geometric Coefficient of Variation 186.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) .
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of BI 208333 (Metabolite of Deleobuvir)
|
6.00 h
Interval 5.0 to 8.0
|
6.00 h
Interval 4.0 to 8.0
|
6.00 h
Interval 4.0 to 8.0
|
6.00 h
Interval 5.0 to 6.0
|
5.01 h
Interval 3.97 to 6.0
|
6.00 h
Interval 5.0 to 8.0
|
6.00 h
Interval 4.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Maximum measured concentration of the analyte in plasma (BI 208333).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of BI 208333 (Metabolite of Deleobuvir)
|
1.82 µmol/L
Geometric Coefficient of Variation 42.8
|
0.59 µmol/L
Geometric Coefficient of Variation 43.6
|
0.92 µmol/L
Geometric Coefficient of Variation 54.2
|
1.32 µmol/L
Geometric Coefficient of Variation 55.0
|
0.58 µmol/L
Geometric Coefficient of Variation 26.8
|
0.86 µmol/L
Geometric Coefficient of Variation 38.9
|
1.19 µmol/L
Geometric Coefficient of Variation 104.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 1200mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞.
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=5 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)
|
15.8 µmol*h/L
Geometric Coefficient of Variation 125.0
|
4.48 µmol*h/L
Geometric Coefficient of Variation 85.8
|
11.0 µmol*h/L
Geometric Coefficient of Variation 55.3
|
12.0 µmol*h/L
Geometric Coefficient of Variation 25.1
|
22.2 µmol*h/L
Geometric Coefficient of Variation 38.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of CD 6168 (Metabolite of Deleobuvir)
|
6.01 h
Interval 5.0 to 8.0
|
7.00 h
Interval 5.0 to 8.0
|
6.00 h
Interval 4.0 to 8.0
|
9.98 h
Interval 5.07 to 10.0
|
6.00 h
Interval 5.02 to 8.0
|
5.50 h
Interval 5.0 to 8.0
|
7.00 h
Interval 5.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Maximum measured concentration of the analyte in plasma (CD 6168).
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
n=6 Participants
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of CD 6168 (Metabolite of Deleobuvir)
|
2.31 µmol/L
Geometric Coefficient of Variation 80.7
|
0.57 µmol/L
Geometric Coefficient of Variation 43.6
|
1.39 µmol/L
Geometric Coefficient of Variation 34.3
|
2.65 µmol/L
Geometric Coefficient of Variation 32.2
|
0.35 µmol/L
Geometric Coefficient of Variation 109.0
|
1.66 µmol/L
Geometric Coefficient of Variation 18.2
|
2.50 µmol/L
Geometric Coefficient of Variation 30.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms "Japanese 400mg", "Japanese 800mg", "Japanese 1200mg" and "Chinese 400mg" cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞.
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=5 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=4 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=4 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)
|
1.27 µmol*h/L
Geometric Coefficient of Variation 114
|
0.56 µmol*h/L
Geometric Coefficient of Variation 17.5
|
1.01 µmol*h/L
Geometric Coefficient of Variation 50.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm "Chinese 400mg" cannot be determined due to limitation of available data above the "below limit of quantification (BLQ)".
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)
|
7.01 h
Interval 5.0 to 8.0
|
8.00 h
Interval 6.0 to 10.0
|
9.98 h
Interval 6.0 to 10.0
|
10.00 h
Interval 5.07 to 10.0
|
6.00 h
Interval 5.0 to 8.0
|
8.00 h
Interval 5.0 to 10.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administrationPopulation: The PK analysis set.
Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm "Chinese 400mg" cannot be determined due to limitation of available data above the "below limit of quantification (BLQ)".
Outcome measures
| Measure |
1200 mg Deleobuvir (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Caucasian Subjects)
n=6 Participants
Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Japanese Subjects)
n=5 Participants
Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200mg Deleobuvir (Japanese Subjects)
n=6 Participants
Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Japanese Subjects)
n=6 Participants
Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir (Chinese Subjects)
Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition.
|
Placebo (Chinese Subjects)
Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)
|
0.13 µmol/L
Geometric Coefficient of Variation 62.3
|
0.03 µmol/L
Geometric Coefficient of Variation 38.0
|
0.08 µmol/L
Geometric Coefficient of Variation 48.2
|
0.11 µmol/L
Geometric Coefficient of Variation 128.0
|
0.05 µmol/L
Geometric Coefficient of Variation 29.0
|
0.07 µmol/L
Geometric Coefficient of Variation 91.6
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
400 mg Deleobuvir
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
800 mg Deleobuvir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1200 mg Deleobuvir
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition.
|
400 mg Deleobuvir
n=12 participants at risk
All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition.
|
800 mg Deleobuvir
n=12 participants at risk
All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition.
|
1200 mg Deleobuvir
n=18 participants at risk
All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
2/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
16.7%
2/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
11.1%
2/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
11.1%
2/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
11.1%
2/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
50.0%
9/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Gastrointestinal disorders
Eructation
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
22.2%
4/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
General disorders
Chills
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
General disorders
Feeling hot
|
0.00%
0/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
8.3%
1/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
11.1%
2/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
11.1%
2/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
0.00%
0/12 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
5.6%
1/18 • Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
Subjects were asked to spontaneously report any AEs as well as the time of onset, duration, and intensity. In addition, specific questions were asked whenever required or useful to more precisely describe an AE.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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