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Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

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ClinicalTrials.gov Identifier: NCT01785160
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Raltegravir Drug: Faldaprevir Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Raltegravir
coated tablets, oral administration with 240 ml water
Drug: Raltegravir
low dose oral administration

Experimental: Raltegravir + Faldaprevir
coated tablets and soft gelatine capsule, oral administration with 240 ml water
Drug: Raltegravir
low dose oral administration

Drug: Faldaprevir
medium dose oral administration




Primary Outcome Measures :
  1. AUC( Tau,ss) [ Time Frame: 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


  2. Cmax ,ss [ Time Frame: 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




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785160


Locations
Germany
1220.65.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01785160     History of Changes
Other Study ID Numbers: 1220.65
2012-004872-21 ( EudraCT Number: EudraCT )
First Posted: February 7, 2013    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action