Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Raltegravir; Drug: Faldaprevir

• Registration Number: NCT01785160
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.

The assessment of safety and tolerability will be an additional objective of this trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-13
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Raltegravir + Faldaprevir	Faldaprevir	coated tablets and soft gelatine capsule, oral administration with 240 ml water
Raltegravir + Faldaprevir	Raltegravir	coated tablets and soft gelatine capsule, oral administration with 240 ml water
Raltegravir	Raltegravir	coated tablets, oral administration with 240 ml water

Primary Outcome Measures

Name	Time	Method
AUC( Tau,ss)	0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration	AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.; The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.; RAL: Raltegravir , FDV: Faldaprevir
Cmax ,ss	0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration	C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.; The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.; RAL: Raltegravir , FDV: Faldaprevir

Trial Locations

Locations (1)

1220.65.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany