Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: BI 201335; Drug: Darunavir; Drug: Ritonavir

• Registration Number: NCT01374802
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Primary Completion: 2011-07
• 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: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 201335	BI 201335	capsule for oral administration
Darunavir 400 mg	Darunavir	tablet for oral administration
Ritonavir 100 mg	Ritonavir	tablet for oral administration

Primary Outcome Measures

Name	Time	Method
AUCτ,ss of Darunavir	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities
Cτ,ss of Darunavir	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir
Cmax,ss of Darunavir	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	maximum measured concentration of the analyte in plasma at steady-state

Secondary Outcome Measures

Name	Time	Method
Tmax,ss of Darunavir	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	time from last dosing to maximum concentration of the analyte in plasma at steady state

Trial Locations

Locations (1)

1220.49.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany