Clinical trial NCT01427504: Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
Official title: A Bioequivalence Study to Evaluate the Potential for Drug-drug Interactions Between Boceprevir 800mg Thrice Daily and the HIV Non-nucleoside Reverse Transcriptase Inhibitor Etravirine 200mg Twice Daily in HIV/(Hepatitis C Virus) (HCV) Negative Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
HIV
Keywords: HCV
HIV
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. Additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.

Detailed description: To investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. The pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be compared.

Eligibility criteria: Inclusion Criteria:

* Men and women ages 18-60 years
* Absence of HIV-1 and HCV antibodies at screening
* Ability and willingness to give written informed consent before the first trial-related activity

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements.
* Participation in any investigation drug study within 30 days prior to study.
* Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results.
* Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry.
* Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis.
* History of significant drug allergy (i.e., anaphylaxis and/or angioedema)
* Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (\>1.1 x upper limit of laboratory normal range (ULN); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above

Primary outcomes:
measure: Boceprevir AUC Pharmacokinetics
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
measure: Boceprevir Cmax Pharmacokinetics
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
measure: Boceprevir C8 Pharmacokinetics
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
measure: Etravirine AUC Pharmacokinetics
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14
measure: Etravirine Cmax Pharmacokinetics
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14
measure: Etravirine Cmin Pharmacokinetics
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14
measure: Boceprevir AUC Pharmacokinetics Coadministered With Etravirine
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
measure: Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine
timeFrame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
measure: Boceprevir C8 Pharmacokinetics Coadministered With Etravirine
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
measure: Etravirine AUC Pharmacokinetics Coadministered With Boceprevir
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14
measure: Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14
measure: Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: Univesity of Colorado Denver
name: Jennifer Kiser, PharmD
role: PRINCIPAL_INVESTIGATOR
References: