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

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ClinicalTrials.gov Identifier: NCT01427504
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C HIV Drug: boceprevir; etravirine Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 Start Date : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1a
Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
 Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
Experimental: Sequence 1b
Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
 Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
Experimental: Sequence 2a
Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
 Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
Experimental: Sequence 2b
Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
 Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
Experimental: Sequence 3a
Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
 Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
Experimental: Sequence 3b
Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
 Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.


Outcome Measures
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Primary Outcome Measures :
  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]


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427504


Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jennifer Kiser, PharmD Univesity of Colorado Denver
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01427504     History of Changes
Other Study ID Numbers: 11-1046
First Posted: September 1, 2011    Key Record Dates
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013
Last Verified: June 2013

Keywords provided by University of Colorado, Denver:
HCV
HIV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Reverse Transcriptase Inhibitors
Etravirine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents