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

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)

The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 207127 NA (low dose); Drug: Matching placebo (low dose); Drug: BI 207127 NA (medium dose); Drug: Matching placebo (medium dose); Drug: BI 207127 NA (high dose); Drug: Matching placebo (high dose)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 1241.8.8201 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. Healthy male volunteers
2. Chinese ethnicity or Japanese ethnicity or Caucasian
3. 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:

1. Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 207127 NA (low dose); Single dose of BI 207127 NA	Drug: BI 207127 NA (low dose); single dose of BI 207127 NA
Placebo Comparator: Matching placebo (low dose); Single dose of matching placebo	Drug: Matching placebo (low dose); single dose of matching placebo
Experimental: BI 207127 NA (medium dose); Single dose of BI 207127 NA	Drug: BI 207127 NA (medium dose); Single does of BI 207127 NA
Placebo Comparator: Matching placebo (medium dose); Single dose of matching placebo	Drug: Matching placebo (medium dose); Single dose of matching placebo
Experimental: BI 207127 NA (high dose); Single dose of BI 207127 NA	Drug: BI 207127 NA (high dose); Single dose of BI 207127 NA
Placebo Comparator: Matching placebo (high dose); Single dose of matching placebo	Drug: Matching placebo (high dose); Single dose of matching placebo

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (Estimate): May 4, 2011

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: March 16, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1241.8