Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers

NCT02244190 | Completed Phase 1

• 1 other identifier: 1182.124
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 72 hours after drug administration

• Cmax (maximum measured concentration of drug in plasma) for tipranavir

  up to 72 hours after drug administration

Secondary Outcomes (14)

• AUC0-∞ for ritonavir

  up to 72 hours after drug administration

• Cmax for ritonavir

  up to 72 hours after drug administration

• AUC0-tz (area under the concentration-time curve of drug 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 drug in plasma)

  up to 72 hours after drug administration

• λz (terminal rate constant of drug in plasma)

  up to 72 hours after drug administration

Study Arms (2)

new Tipranavir + Ritonavir

EXPERIMENTAL

Drug: Tipranavir; Drug: Ritonavir

current Tipranavir + Ritonavir

ACTIVE COMPARATOR

Drug: Tipranavir; Drug: Ritonavir

Interventions

Tipranavir DRUG

New oral solution (back up) formulation

new Tipranavir + Ritonavir

Ritonavir DRUG

Also known as: Norvir®

current Tipranavir + Ritonavir; new Tipranavir + Ritonavir

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, PR), 12-lead ECG, clinical laboratory tests
• Age ≥ 18 and ≤ 55 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2 (Body Mass Index) and body weight \> 55 kg
• 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:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the 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 relevant allergy/hypersensitivity (including allergy to tipranavir or ritonavir or their excipients)
• 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 of the trial drug or during the trial
• Cytochrome P 450 (CYP3A4)-inhibiting drugs (e.g. itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone, cyclosporin, verapamil, amiodarone, diltiazem), CYP3A4 inducing drugs (e.g. St. John´s wort \[Hypericum perforatum\], rifampin, dexamethasone) or CYP3A4 substrates (e.g. triazolam, sertraline); further drugs which might reasonably influence the results of the trial (e.g. drugs which contain polyethylene glycol) or drugs that prolong the QT/corrected QT interval interval (based on the knowledge at the time of protocol preparation) within 14 days prior to first administration of the trial drug or during the trial
• Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking within 24 hours before or after administration of the trial drug
• Alcohol abuse (more than 60 g/day)
• Drug abuse

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 18, 2014
• First Posted: September 19, 2014
• Study Start: April 1, 2008
• Primary Completion: May 1, 2008
• Last Updated: September 19, 2014

Record last verified: 2014-09