Effects of Single-dose and Steady-state TPV/RTV on the Steady-state Pharmacokinetics of Fluconazole in Healthy Adult Volunteers

NCT02195466 | Completed Phase 1

• 1 other identifier: 1182.10
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the steady-state pharmacokinetics of fluconazole

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under plasma concentration time curve from 0-24 hours (AUC0-24h) for FCZ

  up to 24 hours after administration of study drug

• Maximum plasma concentration (Cmax) for FCZ

  up to 24 hours after administration of study drug

• Drug concentration in plasma at 24 hours after administration (Cp24h) for FCZ

  up to 24 hours after administration of study drug

Secondary Outcomes (7)

• AUC0-12h for TPV

  up to 12 hours after administration of study drug

• Cmax for TPV

  up to 24 hours after administration of study drug

• Drug concentration in plasma at 12 hours after administration (Cp12h) for TPV

  up to 12 hours after administration of study drug

• Oral clearance (Cl/F) for FCZ and TPV

  up to 24 hours after administration of study drug

• Time of maximum concentration (tmax) for FCZ and TPV

  up to 24 hours after administration of study drug

Study Arms (1)

TPV + RTV + FCZ

EXPERIMENTAL

Drug: Tipranavir (TPV); Drug: Ritonavir (RTV); Drug: Fluconazole (FCZ)

Interventions

Tipranavir (TPV) DRUG

500 mg bid on days 7-14

TPV + RTV + FCZ

Ritonavir (RTV) DRUG

200 mg bid on days 7-14

TPV + RTV + FCZ

Fluconazole (FCZ) DRUG

200 mg loading dose on day 1, followed by 100 mg qd until day 13

TPV + RTV + FCZ

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects between 18 and 60 years of age inclusive
• A Body Mass Index (BMI) between 18 and 29 kg/m2
• Signed informed consent prior to trial participation
• Ability to swallow multiple large capsules without difficulty
• Acceptable laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity is less than or equal to Grade 1, based on the AIDS Clinical Trials Group (ACTG) Grading Scale. All abnormal laboratory values greater than Grade 1 are subject to approval by the trial clinical monitor
• Acceptable medical history, physical examination, 12-lead electrocardiogram, and chest X-ray (if not conducted within the last 12 months and deemed necessary by investigator) are required prior to entering the treatment phase of the study
• Willingness to abstain from the following starting 14 days prior to any administration of study drugs up until the end of the study:
• Grapefruit or grapefruit juice
• Red wine
• Seville oranges
• St. John's Wort or Milk Thistle
• Willingness to abstain from alcohol starting 2 days prior to administration study drug up to the end of the study
• Willingness to abstain from the following within 72 hours of pharmacokinetics (PK) sampling:
• Garlic supplements
• Methylxanthine containing drinks (coffee, tea, cola, energy drinks, chocolate, etc.)

You may not qualify if:

• Female subjects who are of reproductive potential and:
• Have a positive serum β-human chorionic gonadotropin (hCG) at Visit 1, or on Day 0 or Day 1
• Have not been using a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1)
• Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during the trial and 60 days after completion/termination
• Are breast-feeding
• Participation in another trial with an investigational medicine within 60 days prior to Day 0 (Visit 2)
• Use of any prohibited medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
• Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month of study initiation and for the duration of the study. Use of Depo-Provera is excluded for six months prior to study initiation
• Use of hormone replacement therapy within 1 month of study initiation and for the duration of the study
• Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
• History of acute illness within the past 60 days. Subjects will be excluded for these disorders greater than sixty days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
• History of thrombotic disease
• History of migraine headache
• Have serological evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Have serological evidence of exposure to HIV

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; Ritonavir; Fluconazole

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 21, 2014
• Study Start: June 1, 2003
• Primary Completion: July 1, 2003
• Last Updated: July 21, 2014

Record last verified: 2014-07