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Completed

NCT Number: NCT01427504

Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HIV Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

boceprevir; etravirine

Drug

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Primary outcomes

  1. Boceprevir AUC Pharmacokinetics

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

    Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.

  2. Boceprevir Cmax Pharmacokinetics

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

    Determine the Cmax of boceprevir when administered alone.

  3. Boceprevir C8 Pharmacokinetics

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

    Determine boceprevir 8 hour concentration when administered alone.

  4. Etravirine AUC Pharmacokinetics

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14

    Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.

  5. Etravirine Cmax Pharmacokinetics

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14

    Determine etravirine Cmax when administered alone

  6. Etravirine Cmin Pharmacokinetics

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14

    Determine etravirine Cmin when administered alone

  7. Boceprevir AUC Pharmacokinetics Coadministered With Etravirine

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

    Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]

  8. Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine

    Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

    Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]

  9. Boceprevir C8 Pharmacokinetics Coadministered With Etravirine

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

    Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]

  10. Etravirine AUC Pharmacokinetics Coadministered With Boceprevir

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14

    Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]

  11. Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14

    Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]

  12. Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14

    Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 1, 2011
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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