Relative Bioavailability of Tipranavir (TPV)/Ritonavir (RTV) at Steady State Administered as Oral Solutions vs. Capsules in the Fed and Fasted State in Healthy Volunteers

NCT02227017 | Completed Phase 1

• 1 other identifier: 1182.100
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted and fed conditions in healthy male and female volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve of TPV from time zero to 12 hours at steady state (AUC0-12)

  up to 12 hours after drug administration

Secondary Outcomes (10)

• Area under the concentration-time curve of RTV from time zero to 12 hours at steady state (AUC0-12)

  up to 12 hours after drug administration

• Maximum measured concentration of the analyte in plasma at steady state (Cmax)

  up to 12 hours after drug administration

• Drug concentration in plasma after 12 hours at steady state (Cp12h)

  up to 12 hours after drug administration

• Apparent clearance of the analyte in plasma at steady state following extravascular administration (CL/F)

  up to 12 hours after drug administration

• Volume of distribution at steady state (Vd)

  up to 12 hours after drug administration

Study Arms (4)

TPV/RTV capsules fed

EXPERIMENTAL

Drug: TPV capsule; Drug: RTV capsule; Other: standard meal

TPV/RTV capsules fasted

EXPERIMENTAL

Drug: TPV capsule; Drug: RTV capsule

TPV/RTV solutions fed

ACTIVE COMPARATOR

Drug: TPV solution; Drug: RTV solution; Other: standard meal

TPV/RTV solutions fasted

ACTIVE COMPARATOR

Drug: TPV solution; Drug: RTV solution

Interventions

TPV capsule DRUG

TPV/RTV capsules fasted; TPV/RTV capsules fed

TPV solution DRUG

TPV/RTV solutions fasted; TPV/RTV solutions fed

RTV capsule DRUG

TPV/RTV capsules fasted; TPV/RTV capsules fed

RTV solution DRUG

TPV/RTV solutions fasted; TPV/RTV solutions fed

standard meal OTHER

TPV/RTV capsules fed; TPV/RTV solutions fed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 to 65 years of age inclusive
• A Body Mass Index (BMI): ≥18.5 and ≤35 kg/m2
• Signed informed consent prior to performance of any study procedures
• Ability to swallow multiple large capsules without difficulty
• Acceptable medical history, physical examination, and 12-lead ECG at screening
• Willingness to abstain from the following starting 5 days 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
• Willingness to abstain from the following starting 3 days prior to administration of any study medication up to the end of the study:
• Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.), apples and apple juice
• Willingness to abstain from over-the-counter herbal medications for the duration of the study
• Are non-smokers
• Willingness to abstain from vigorous physical exercise during intensive pharmacokinetic days 10, 11, 14, 15
• Reasonable probability for completion of the study

You may not qualify if:

• Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
• Female subjects of reproductive potential who:
• Have a positive 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
• Use any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study. Due to long half-life, subjects using Depo-Provera® within 6 months prior to Day 1 are excluded from participation in this study
• Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study
• Use of any medication listed in Protocol within 30 days prior to Day 0 of this study
• Administration of antibiotics within 15 days prior to Day 0 and anytime during the study
• History of acute illness within 60 days prior to Day 0
• Subjects will be excluded for acute illnesses that occurred more than 60 days prior to Day 0 if, in the opinion of the investigator, the subject did not qualify as a healthy volunteer
• Serological evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Serological evidence of exposure to HIV
• Alcohol or substance abuse within 1 year prior to screening or during the study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: February 1, 2006
• Primary Completion: April 1, 2006
• Last Updated: August 27, 2014

Record last verified: 2014-08