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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01347086
First received: May 3, 2011
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.

Condition Intervention Phase
Healthy
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)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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:
  • AUC0-∞ of Deleobuvir [ Time Frame: -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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).

  • Cmax of Deleobuvir [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma (Deleobuvir).

  • AUC0-∞ of BI 208333 (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) .

  • Cmax of BI 208333 (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma (BI 208333).

  • AUC0-∞ of CD 6168 (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168).

  • Cmax of CD 6168 (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma (CD 6168).

  • AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    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-∞.

  • Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]
    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)".

  • Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir) [ Time Frame: -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 ] [ Designated as safety issue: No ]

    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)".



Enrollment: 60
Study Start Date: May 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347086

Locations
Korea, Republic of
1241.8.8201 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01347086     History of Changes
Other Study ID Numbers: 1241.8 
Study First Received: May 3, 2011
Results First Received: January 21, 2016
Last Updated: March 16, 2016
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on July 27, 2016