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

Phase 1

Completed

• Conditions: Healthy
• Interventions: 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)

• Registration Number: NCT01347086
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Primary Completion: 2011-06
• Results First Submitted: 2016-01-21
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Results First Posted: 2016-04-15
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 207127 NA (low dose)	BI 207127 NA (low dose)	Single dose of BI 207127 NA
Matching placebo (low dose)	Matching placebo (low dose)	Single dose of matching placebo
BI 207127 NA (medium dose)	BI 207127 NA (medium dose)	Single dose of BI 207127 NA
Matching placebo (medium dose)	Matching placebo (medium dose)	Single dose of matching placebo
BI 207127 NA (high dose)	BI 207127 NA (high dose)	Single dose of BI 207127 NA
Matching placebo (high dose)	Matching placebo (high dose)	Single dose of matching placebo

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Drug Related Adverse Events	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	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 Outcome Measures

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

Trial Locations

Locations (1)

1241.8.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of