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

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.

Official Title
-----------------
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)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: 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)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 207127 NA (low dose)<br>Single dose of BI 207127 NA | Drug: BI 207127 NA (low dose)<br>* single dose of BI 207127 NA<br>|
| Placebo Comparator: Matching placebo (low dose)<br>Single dose of matching placebo | Drug: Matching placebo (low dose)<br>* single dose of matching placebo<br>|
| Experimental: BI 207127 NA (medium dose)<br>Single dose of BI 207127 NA | Drug: BI 207127 NA (medium dose)<br>* Single does of BI 207127 NA<br>|
| Placebo Comparator: Matching placebo (medium dose)<br>Single dose of matching placebo | Drug: Matching placebo (medium dose)<br>* Single dose of matching placebo<br>|
| Experimental: BI 207127 NA (high dose)<br>Single dose of BI 207127 NA | Drug: BI 207127 NA (high dose)<br>* Single dose of BI 207127 NA<br>|
| Placebo Comparator: Matching placebo (high dose)<br>Single dose of matching placebo | Drug: Matching placebo (high dose)<br>* Single dose of matching placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Drug Related Adverse Events | 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. | From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days. | 
| Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG | 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). | From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ of Deleobuvir | Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞). | -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 | Time from dosing to the maximum measured concentration of the analyte in plasma (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 | Maximum measured concentration of the analyte in plasma (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) | 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-∞. | -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) | Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) . | -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) | Maximum measured concentration of the analyte in plasma (BI 208333). | -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) | 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-∞. | -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) | Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168). | -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) | Maximum measured concentration of the analyte in plasma (CD 6168). | -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) | 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-∞. | -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) | 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). | -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) | 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). | -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 |