Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Faldaprevir Effect on Steady State Pharmacokinetics of Raltegravir in Healthy Male and Female Volunteers (an Open-label Trial With Two Periods in a Fixed Sequence)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Raltegravir
* Drug: Raltegravir
* Drug: Faldaprevir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Raltegravir<br>coated tablets, oral administration with 240 ml water | Drug: Raltegravir<br>* low dose oral administration<br>|
| Experimental: Raltegravir + Faldaprevir<br>coated tablets and soft gelatine capsule, oral administration with 240 ml water | Drug: Raltegravir<br>* low dose oral administration<br>Drug: Faldaprevir<br>* medium dose oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC( Tau,ss) | 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 | 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 | 
| Cmax ,ss | 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 | 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 |