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 - Full Text View

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 Pharmaceuticals:

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 ]

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

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 Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01737996 History of Changes
Other Study ID Numbers:	1241.35, 2012-003697-10
Study First Received:	November 26, 2012
Last Updated:	April 17, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013