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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22
1220.50.0001 Boehringer Ingelheim Investigational Site
Buffalo, New York, United States
Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and 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.
Time frame: 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
Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Time frame: 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
Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
Time frame: 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
Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and 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.
Time frame: 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
Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Time frame: 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
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Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
Time frame: 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
Number of Patients With Drug Related Adverse Events During the Trial
Outcome data are the numbers of subjects with investigator defined drug-related AEs
Time frame: From drug administration up to 32 days.
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
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
Time frame: From drug administration up to 32 days.