Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects

NCT02251158 | Completed Phase 1

• 1 other identifier: 1182.45
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ (area under the concentration time curve of tipranavir in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours after drug administration

• Cmax (maximum concentration of tipranavir in plasma)

  up to 72 hours after drug administration

Secondary Outcomes (7)

• AUC0-tz (area under the concentration-time curve of tipranavir in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 72 hours after drug administration

• tmax (time from dosing to the maximum concentration of tipranavir in plasma)

  up to 72 hours after drug administration

• t1/2 (terminal half-life of tipranavir in plasma)

  up to 72 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after oral administration)

  up to 72 hours after drug administration

• CLpo/F (apparent clearance of tipranavir in the plasma after extravascular administration)

  up to 72 hours after drug administration

Study Arms (3)

TPV/r with food

EXPERIMENTAL

Tipranavir/Ritonavir paediatric/oral solution

Drug: Tipranavir oral solution; Drug: Ritonavir oral solution; Other: High fat breakfast

TPV/r

EXPERIMENTAL

Tipranavir/Ritonavir paediatric/oral solution

Drug: Tipranavir oral solution; Drug: Ritonavir oral solution

TPV/r capsules

ACTIVE COMPARATOR

Drug: Tipranavir capsules; Drug: Ritonavir soft gel capsules

Interventions

Tipranavir oral solution DRUG

TPV/r; TPV/r with food

Tipranavir capsules DRUG

TPV/r capsules

Ritonavir oral solution DRUG

TPV/r; TPV/r with food

Ritonavir soft gel capsules DRUG

TPV/r capsules

High fat breakfast OTHER

TPV/r with food

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 18 and Age ≤ 55 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial (e.g. drugs which contain polyethylene glycol or vitamin E)
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2014-09