TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers. - Full Text View

Sponsored by:	Tibotec Pharmaceuticals Limited, Ireland
Information provided by:	Tibotec Pharmaceuticals Limited, Ireland
ClinicalTrials.gov Identifier:	NCT00744887

Purpose

The objectives are to determine the effect of different ritonavir doses on darunavir (DRV) oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and tolerability.

Condition	Intervention	Phase
HIV AIDS	Drug: Darunavir	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	Phase I, Open-Label, Randomized, 3-Way Crossover Trial to Assess the Pharmacokinetics of Darunavir (DRV) Given Once-Daily With Different Doses of Ritonavir in Healthy Subjects.

Further study details as provided by Tibotec Pharmaceuticals Limited, Ireland:

Primary Outcome Measures:

To determine the effect of different ritonavir doses (20, 50, 100 mg ritonavir) in DRV oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritonavir boosting dose for DRV

Secondary Outcome Measures:

To evaluate short-term safety and tolerability of DRV following administration of DRV 800 mg once-daily in the presence of different doses of ritonavir for 7 days in healthy volunteers

Estimated Enrollment:	18
Study Start Date:	August 2008

Detailed Description:

This is a Phase I, open-label, randomized (study drug assigned by chance), 3-way crossover trial in healthy volunteers to assess the pharmacokinetics of darunavir (DRV), co-administered with different doses of ritonavir. The trial population will consist of 18 healthy adult volunteers. During 3 subsequent sessions, each volunteer will receive in a randomized way: Treatments A, B and C. In Treatment A, 800 mg DRV once-daily and 100 mg ritonavir once-daily will be administered. In Treatment B, 800 mg DRV once-daily and 50 mg ritonavir once-daily will be administered. In Treatment C, 800 mg DRV once-daily and 20 mg ritonavir once-daily will be administered. All treatments will be administered for 7 days and intake of DRV and ritonavir will be under fed conditions. DRV will be formulated as a 400 mg tablet; ritonavir will be formulated as an oral solution containing 80mg/mL ritonavir. In each treatment session, full pharmacokinetic profiles of DRV and ritonavir will be determined up to 24 hours after administration on Day 1 and up to 72 hours after administration on Day 7. There will be a washout period of at least 7 days between subsequent treatments. Safety and tolerability will be evaluated continuously throughout the trial.

During 3 subsequent sessions, each volunteer will receive in a randomized way Treatments A, B and C. In Treatment A, 800/100 mg DRV/rtv once-daily will be administered. In Treatment B, 800/50 mg DRV/rtv once-daily will be administered. In Treatment C, 800/20 mg DRV/rtv once-daily will be administered. All treatments will be administered for 7 days. DRV will be formulated as a 400 mg tablet; ritonavir will be formulated as an oral solution containing 80mg/mL ritonavir.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening

Exclusion Criteria:

A positive HIV-1 or HIV-2 test at screening
Hepatitis A, B, or C infection (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen [with a positive hep B PCR], or hepatitis C virus antibody, respectively) at Screening
Any history of significant skin disease such as, but not limited to, rash or eruptions, food or drug allergy, dermatitis, eczema, psoriasis, folliculitis, or urticaria
Use of concomitant medication, including over-the-counter products, herbal preparations and dietary supplements. Concomitant medication must have been discontinued at least 14 days before the first dose of trial medication except for paracetamol (acetaminophen), hormone replacement therapy and hormonal contraceptives
Participation in an investigational drug trial within 60 days prior to the first intake of trial medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744887

Sponsors and Collaborators

Tibotec Pharmaceuticals Limited, Ireland

Investigators

Study Director:

Tibotec Pharmaceuticals Limited Clinical Trial

Tibotec Pharmaceuticals Limited, Ireland

More Information

Study ID Numbers:	CR015421
Study First Received:	August 29, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00744887
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tibotec Pharmaceuticals Limited, Ireland:

TMC114-TiDP3-C181
TMC114-C181, health volunteers, Darunavir, ritonavir oral solution

Study placed in the following topic categories:

Ritonavir
HIV Infections
Acquired Immunodeficiency Syndrome
Healthy
Darunavir

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009