Drug Drug Interaction of BI 201335 and Tenofovir

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: tenofovir/BI 201335

• Registration Number: NCT01340196
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2011-06
• 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: 16

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sequence 1	tenofovir/BI 201335	tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only)

Primary Outcome Measures

Name	Time	Method
Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15	144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15	Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15	144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15	Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15	144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15	Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22	168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22	Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22	168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22	Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22	168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22	Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Drug Related Adverse Events During the Trial	From drug administration up to 32 days.	Outcome data are the numbers of subjects with investigator defined drug-related AEs
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG	From drug administration up to 32 days.	Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.; Preferred term of relevant AE: Presyncope

Trial Locations

Locations (1)

1220.50.0001 Boehringer Ingelheim Investigational Site; 🇺🇸 Buffalo, New York, United States