Effects of Single-dose and Steady-state TPV/r on the Steady-state Pharmacokinetics of Clarithromycin and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir

NCT02251769 | Completed Phase 1

• 1 other identifier: 1182.11
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500 mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  up to 12 hours

• Maximum plasma concentration (Cmax)

  up to 12 hours

• Plasma trough concentration (Cp12h)

  up to 12 hours

Secondary Outcomes (7)

• Oral clearance (CL/F)

  up to 12 hours

• Volume of distribution (V)

  up to 12 hours

• Apparent terminal half life (t1/2)

  up to 12 hours

• Time of maximum concentration (Tmax)

  up to 12 hours

• Mean Residency Time (MRT)

  up to 12 hours

Study Arms (1)

Sequential administration

EXPERIMENTAL

Drug: Tipranavir; Drug: Ritonavir; Drug: Clarithromycin; Other: High-Fat Test Meal

Interventions

Tipranavir DRUG

Sequential administration

Ritonavir DRUG

Sequential administration

Clarithromycin DRUG

Sequential administration

High-Fat Test Meal OTHER

Sequential administration

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 capsules without difficulty
• Ability to ingest a standard high-fat test meal
• Acceptable laboratory values that indicated adequate baseline organ function were required at the time of screening. Laboratory values were considered to be acceptable if severity was less than or equal to Grade 1, based on the AIDS Clinical Trials Group (ACTG) Grading Scale
• Acceptable medical history, physical examination and 12-lead ECG were required prior to entering the treatment phase of the study
• Willingness to abstain from alcohol for 48 hours prior to study Day 0 and abstain from alcohol for the duration of the study. In addition, ingestion of red wine is not allowed within 5 days prior to Day 0 (Visit 2)
• Willingness to abstain from grapefruit or grapefruit juice or products containing grapefruit juice starting 10 days prior to any administration of study drug up until the end of the study
• Willingness to abstain from ingestion of Seville oranges, garlic supplements, St. John's Wort, or Milk Thistle, within 5 days of treatment and for the duration of the study
• Willingness to abstain from methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) within 48 hours of each pharmacokinetic sampling day and until after the last sample from each of the intensive sampling days was collected
• Willingness to abstain from over the counter herbal medications for the duration of the study
• Willingness to abstain from vigorous physical exercise during intensive pharmacokinetic days
• Reasonable probability for completion of the study
• Non-smokers for at least 3 months prior to Day 0

You may not qualify if:

• Female subjects who are of reproductive potential and who:
• Have positive serum β-hCG at Visit 1, or on Day 0
• Are not using a barrier contraceptive method for at least 3 months prior to Visit 2 (Day 0)
• Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms), during the trial and for 30 days after trial completion/termination
• Are breast-feeding
• Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to study initiation and for the duration of the study
• Use of hormone replacement therapy within 1 month prior to study initiation and for the duration of the study
• 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)
• Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
• History of acute illness within 60 days of trial initiation. Subjects are excluded for these disorders greater than 60 days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
• Serological evidence of hepatitis B (HBV) or hepatitis C (HCV)
• Serological evidence of exposure to HIV
• Recent history of alcohol or substance abuse (within 6 months of study period)
• Blood or plasma donations within 30 days prior to Day 0 (Visit 2) or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; Ritonavir; Clarithromycin

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

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 25, 2014
• First Posted: September 29, 2014
• Study Start: August 1, 2003
• Primary Completion: September 1, 2003
• Last Updated: September 29, 2014

Record last verified: 2014-09