NCT01785160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

August 3, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

28 days

First QC Date

December 13, 2012

Results QC Date

July 3, 2015

Last Update Submit

July 3, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Raltegravir

ACTIVE COMPARATOR

coated tablets, oral administration with 240 ml water

Drug: Raltegravir

Raltegravir + Faldaprevir

EXPERIMENTAL

coated tablets and soft gelatine capsule, oral administration with 240 ml water

Drug: RaltegravirDrug: Faldaprevir

Interventions

RaltegravirDRUG

low dose oral administration

Raltegravir
FaldaprevirDRUG

medium dose oral administration

Raltegravir + Faldaprevir

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. healthy male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1220.65.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

MeSH Terms

Interventions

Raltegravir Potassiumfaldaprevir

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 3, 2015

Results First Posted

August 3, 2015

Record last verified: 2015-07

Locations

DE(1)