Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir

NCT02253836 | Completed Phase 1

• 1 other identifier: 1182.61
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the single-dose and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with Ritonavir (100 mg). To investigate the effects of single-dose and steady-state Atazanavir (300 mg) on the steady-state pharmacokinetics of Tipranavir and Ritonavir.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Maximum plasma concentration

  up to day 33

• Drug concentration in plasma at 12 hr after administration for Tipranavir (TPV) and Ritonavir (RTV)

  12 hours after drug administration

• Drug concentration in plasma at 24 hr after administration for Atazanavir (TAZ)

  24 hours after drug administration

• Area under plasma concentration time curve from 0-12 hours (AUC0-12h) for TPV and RTV

  up to 12 hours after drug administration

• AUC0-24h for TAZ

  up to 24 hours after drug administration

Secondary Outcomes (5)

• Time from dosing to the maximum concentration

  up to day 33

• Elimination half-life

  up to day 33

• Oral clearance

  up to day 33

• Volume of distribution

  up to day 33

• Number of patients with adverse events

  up to day 33

Study Arms (1)

TAZ/RTV - TPV/RTV - TPV/RTV+TAZ

EXPERIMENTAL

Days 1-9: single dose TAZ/RTV Days 16-23: morning and evening dose TPV/RTV Days 24-32: TPV/RTV + TAZ

Drug: Tipranavir; Drug: Ritonavir; Drug: Atazanavir

Interventions

Tipranavir DRUG

TPV

TAZ/RTV - TPV/RTV - TPV/RTV+TAZ

Ritonavir DRUG

RTV

TAZ/RTV - TPV/RTV - TPV/RTV+TAZ

Atazanavir DRUG

TAZ

TAZ/RTV - TPV/RTV - TPV/RTV+TAZ

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 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/AIDS Clinical Trials Group Grading Scale
• All abnormal laboratory values \> Grade 1 are subject to approval by the trial clinical monitor
• Acceptable medical history, physical examination, and 12-lead ECG at screening
• 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
• Willingness to abstain from alcohol starting 3 days prior to administration of any study medication up to the end of the study
• 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.)
• Willingness to abstain from over-the-counter herbal medications for the duration of the study
• Must be a non-smoker

You may not qualify if:

• 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
• Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
• Use of any medication listed in the protocol within 30 days prior to Day 0 of this study
• Use of 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 of Depo-Provera within six months prior to Day 0 will be excluded from participation in this study
• Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the 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
• o 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 does not qualify as a healthy volunteer
• Have serological evidence of hepatitis B or C virus
• Have 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

tipranavir; Ritonavir; Atazanavir Sulfate

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

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: September 30, 2014
• First Posted: October 1, 2014
• Study Start: January 1, 2005
• Primary Completion: July 1, 2005
• Last Updated: October 1, 2014

Record last verified: 2014-09