- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00744887
TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.
June 8, 2011 updated by: Tibotec Pharmaceuticals, Ireland
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.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 29, 2008
First Submitted That Met QC Criteria
August 29, 2008
First Posted (Estimate)
September 1, 2008
Study Record Updates
Last Update Posted (Estimate)
June 9, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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