Phase 1
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
Bottom Line
View on ClinicalTrials.gov: NCT01347086 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Subjects With Drug Related Adverse Events — 5; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Matching placebo (low dose) (Drug); BI 207127 NA (medium dose) (Drug); BI 207127 NA (low dose) (Drug); Matching placebo (medium dose) (Drug); BI 207127 NA (high dose) (Drug); Matching placebo (high dose) (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2011
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 | — |
Summary
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
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.