Phase 1
Completed N=60
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
Healthy
Source: ClinicalTrials.gov NCT01347086 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Number of Subjects With Drug Related Adverse Events — 5; 1; 0; 0 Participants
Summary
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Drug Related Adverse Events |
5; 1; 0; 0; 5; 2 | — |
| PRIMARY Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY AUC0-∞ of Deleobuvir |
61.2; 14.0; 31.4; 48.2; 8.7; 42.6 | — |
| SECONDARY Tmax of Deleobuvir |
6.01; 4.51; 5.50; 5.00; 4.50; 5.00 | — |
| SECONDARY Cmax of Deleobuvir |
11.8; 3.2; 6.41; 8.26; 2.32; 8.89 | — |
| SECONDARY AUC0-∞ of BI 208333 (Metabolite of Deleobuvir) |
12.7; 10.1; 5.97; 9.01 | — |
| SECONDARY Tmax of BI 208333 (Metabolite of Deleobuvir) |
6.00; 6.00; 6.00; 6.00; 5.01; 6.00 | — |
| SECONDARY Cmax of BI 208333 (Metabolite of Deleobuvir) |
1.82; 0.59; 0.92; 1.32; 0.58; 0.86 | — |
| SECONDARY AUC0-∞ of CD 6168 (Metabolite of Deleobuvir) |
15.8; 4.48; 11.0; 12.0; 22.2 | — |
| SECONDARY Tmax of CD 6168 (Metabolite of Deleobuvir) |
6.01; 7.00; 6.00; 9.98; 6.00; 5.50 | — |
| SECONDARY Cmax of CD 6168 (Metabolite of Deleobuvir) |
2.31; 0.57; 1.39; 2.65; 0.35; 1.66 | — |
| SECONDARY AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) |
1.27; 0.56; 1.01 | — |
| SECONDARY Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) |
7.01; 8.00; 9.98; 10.00; 6.00; 8.00 | — |
| SECONDARY Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) |
0.13; 0.03; 0.08; 0.11; 0.05; 0.07 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male volunteers
- Chinese ethnicity or Japanese ethnicity or Caucasian
- Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and BMI = 29.9 kg/m2 for Caucasians
Exclusion criteria
- Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Data sourced from ClinicalTrials.gov (NCT01347086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.