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)
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedResults Posted
Study results publicly available
April 15, 2016
CompletedApril 15, 2016
March 1, 2016
1 month
May 3, 2011
January 21, 2016
March 16, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (6)
BI 207127 NA (low dose)
EXPERIMENTALSingle dose of BI 207127 NA
Matching placebo (low dose)
PLACEBO COMPARATORSingle dose of matching placebo
BI 207127 NA (medium dose)
EXPERIMENTALSingle dose of BI 207127 NA
Matching placebo (medium dose)
PLACEBO COMPARATORSingle dose of matching placebo
BI 207127 NA (high dose)
EXPERIMENTALSingle dose of BI 207127 NA
Matching placebo (high dose)
PLACEBO COMPARATORSingle dose of matching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1241.8.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 4, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2011
Last Updated
April 15, 2016
Results First Posted
April 15, 2016
Record last verified: 2016-03