Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01737996
First received: November 26, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.


Condition Intervention Phase
Healthy
Drug: BI 207127
Drug: BI 207127 + faldaprevir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUCt (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma over a uniform dosing interval t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • Ct (concentration of the analyte in plasma at steady state at the end of the dosing interval t) (only for BI 207127 and metabolites) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • Ct,ss (concentration of the analyte in plasma at steady state at the end of the dosing interval t) (only for BI 207127 and metabolites) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • C12 (measured concentration of the analyte in plasma at 12 hours) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • AUC0-infinity area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • %AUCtz-infinity (the percentage of AUC0-infinity obtained by extrapolation) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • C12,ss (measured concentration of the analyte in plasma at steady state at 12 hours) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • RA,Cmax (accumulation ratio based on Cmax,ss) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
  • RA,AUC (accumulation ratio based on AUC0-t) [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 207127 bid low dose
tablets, oral administration with 240 mL water under fed conditions
Drug: BI 207127
tablets, oral administration
Experimental: BI 207127 bid high dose
tablets, oral administration with 240 mL water under fed conditions
Drug: BI 207127
tablets, oral administration
Experimental: BI 207127 bid high dose+faldaprevir qd
tablets/capsules, oral administration with 240 mL water under fed conditions
Drug: BI 207127 + faldaprevir
fixed dose combination

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  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: NCT01737996

Locations
Germany
1241.35.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01737996     History of Changes
Other Study ID Numbers: 1241.35, 2012-003697-10
Study First Received: November 26, 2012
Last Updated: July 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014