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Effects of Steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir Concentration at Steady-state in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02226991
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the effects of steady-state Efavirenz (600 mg QD) on the steady-state pharmacokinetics of Tipranavir (500 mg BID) coadministered with Ritonavir (200 mg BID)

Condition or disease Intervention/treatment Phase
Healthy Drug: Tipranavir Drug: Ritonavir Drug: Efavirenz Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centre, Open-label Study to Assess the Effects of Steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir Concentration When Tipranavir/Ritonavir Are Administered at Doses 500 mg/200 mg BID to Steady-state in Healthy Adult Volunteers
Study Start Date : April 2006
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPV/RTV/EFV
tipranavir (TPV) + ritonavir (RTV) from day 1 to day 24 efavirenz (EFV) from day 10 to day 23
Drug: Tipranavir
Drug: Ritonavir
Drug: Efavirenz



Primary Outcome Measures :
  1. Maximum plasma concentration at steady state (Cmax) [ Time Frame: up to 12 hours after drug administration ]
  2. Drug concentration in plasma at 12 hours after administration (Cp12h) [ Time Frame: up to 12 hours after drug administration ]
    Tipranavir (TPV)

  3. Last measured drug concentration in plasma (Cplast) [ Time Frame: up to 12 hours after drug administration ]
    Ritonavir (RTV)

  4. Area under plasma concentration time curve from 0-12 hours (AUC0-12h) [ Time Frame: up to 12 hours after drug administration ]

Secondary Outcome Measures :
  1. Trough plasma concentration (Cmin) [ Time Frame: before drug administration ]
  2. Time from dosing to the maximum concentration (tmax) [ Time Frame: up to 12 hours after drug administration ]
  3. Elimination half-life (t1/2) [ Time Frame: up to 12 hours after drug administration ]
  4. Oral clearance (CL/F) [ Time Frame: up to 12 hours after drug administration ]
  5. Volume of distribution (Vz/F) [ Time Frame: up to 12 hours after drug administration ]
  6. Number of subjects with adverse events [ Time Frame: up to 38 days after first drug administration ]
  7. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 38 days after first drug administration ]


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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:

  1. Male or female subjects between 18 and 60 years of age inclusive
  2. A Body Mass Index (BMI) between 18 and 29.9 kg/m2
  3. Signed informed consent prior to trial participation
  4. Ability to swallow multiple large capsules without difficulty
  5. Acceptable laboratory values that indicate adequate baseline organ function at screening visit

    • Laboratory values are considered to be acceptable if the severity of any parameter is ≤Grade 1, based on the Division of AIDS (DAIDS)/AIDS Clinical Trials Group (ACTG) Grading Scale
    • All abnormal laboratory values >Grade 1 are subject to approval by the BI trial clinical monitor
  6. Acceptable medical history, physical examination, and 12-lead ECG at screening
  7. Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:

    • Grapefruit or grapefruit juice, red wine, Seville oranges, St. John's Wort, and Milk Thistle
  8. Willingness to abstain from alcohol starting 3 days prior to administration of any study medication up to the end of the study
  9. Willingness to abstain from the following starting 3 days prior to pharmacokinetic (PK) sampling:

    • Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.), apples or apple juice
  10. Willingness to abstain from over-the-counter herbal medications for the duration of the study
  11. Must be a non-smoker
  12. Willingness to abstain from vigorous physical exercise during intensive PK days; Days 10 and 24
  13. Reasonable probability for completion of the study

Exclusion Criteria:

  1. Female subjects of reproductive potential who:

    • Have positive serum pregnancy test
    • Have not been using a barrier method of contraception for at least 3 months prior to participation in the study
    • Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial
    • Are breast-feeding.
  2. Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 1 and for the duration of the study.

    Due to long half-life, subjects using Depo-Provera® within six months prior to Day 1 will be excluded from participation in this study

  3. Use of hormone replacement therapy within 1 month prior to Day 1 and anytime during the study
  4. Participation in another trial with an investigational medicine within 2 months prior to Day 1 of this study
  5. Use of any medication listed in Appendix 10.5 within 30 days prior to Day 1 of this study
  6. Administration of antibiotics within 15 days prior to Day 1 and anytime during the study
  7. History of acute illness within 60 days prior to Day 1

    • Subjects will be excluded for acute illnesses that occurred more than 60 days prior to Day 1 if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
  8. Have serological evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
  9. Have serological evidence of exposure to HIV
  10. Alcohol or substance abuse within 1 year prior to screening or during the study
  11. Blood or plasma donations within 30 days prior to Day 1 or during the study
  12. Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV, RTV or EFV to the subject
  13. History of a psychiatric disorder that required pharmacological or other psychological treatment
  14. Subjects who have taken (within 7 days prior to Day 1) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the sponsor's clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications
  15. Known hypersensitivity to sulphonamide class of drugs
  16. Known hypersensitivity to TPV, RTV, EFV or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
  17. Known elevated liver enzymes in past trials with any compound
  18. Inability to adhere to the protocol
  19. Cautions or warnings in the RTV and EFV package insert which, in the opinion of the investigator, constitute grounds for subject exclusion

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02226991     History of Changes
Other Study ID Numbers: 1182.102
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Ritonavir
Tipranavir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers