Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400mg, 800mg, 1200mg) of BI 207127 NA in Healthy Male Asian Volunteers and Single Oral Dose (1200 mg) of BI 207127 NA in Healthy Male Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Group)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Drug Related Adverse Events
Study Overview
Brief Summary
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 207127 NA (low dose)
Single dose of BI 207127 NA
Intervention: BI 207127 NA (low dose) (Drug)
Matching placebo (low dose)
Single dose of matching placebo
Intervention: Matching placebo (low dose) (Drug)
BI 207127 NA (medium dose)
Single dose of BI 207127 NA
Intervention: BI 207127 NA (medium dose) (Drug)
Matching placebo (medium dose)
Single dose of matching placebo
Intervention: Matching placebo (medium dose) (Drug)
BI 207127 NA (high dose)
Single dose of BI 207127 NA
Intervention: BI 207127 NA (high dose) (Drug)
Matching placebo (high dose)
Single dose of matching placebo
Intervention: Matching placebo (high dose) (Drug)
Outcomes
Primary Outcomes
Number of Subjects With Drug Related Adverse Events
Time Frame: From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.
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.
Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
Time Frame: From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.
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).
Secondary Outcomes
- AUC0-∞ of Deleobuvir(-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 administration)
- Tmax of Deleobuvir(-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 administration)
- Cmax of Deleobuvir(-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 administration)
- AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)(-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 administration)
- Tmax of BI 208333 (Metabolite of Deleobuvir)(-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 administration)
- Cmax of BI 208333 (Metabolite of Deleobuvir)(-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 administration)
- AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)(-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 administration)
- Tmax of CD 6168 (Metabolite of Deleobuvir)(-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 administration)
- Cmax of CD 6168 (Metabolite of Deleobuvir)(-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 administration)
- AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)(-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 administration)
- Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)(-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 administration)
- Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)(-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 administration)