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TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00752310
First Posted: September 15, 2008
Last Update Posted: June 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tibotec Pharmaceuticals, Ireland
  Purpose
The purpose of this study is to evaluate in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability).

Condition Intervention Phase
Pharmacokinetics Drug: Darunavir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Randomized, Crossover Trial in Healthy Subjects Receiving DRV Combined With RTV Low Dose to Compare the Oral Bioavailability of DRV Suspension to That of DRV 300 mg Tablet Under Fasted and Fed Conditions, and to Assess Multiple Dose Pharmacokinetics of the DRV Suspension

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • Part 1: plasma concentrations of DRV and RTV. Time frame day 3: predose and up to 12h, then at 24, 48, 72h. Part 2: plasma concentrations of DRV and RTV. Time frame: predose day 1 and day 5-6; day 7 predose and up to 12h, then at 24, 48, 72h.

Secondary Outcome Measures:
  • Short term safety and tolerability of DRV, formulated as suspension or as tablet, in the presence of low-dose RTV.

Enrollment: 23
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:
The objectives of this trial are in Part 1 to compare the rate and extent of absorption of a single oral dose of 600 mg darunavir (DRV) administered as the suspension formulation F051 (under fed and fasted conditions) to that of the commercial tablet formulation F016 (under fed conditions), in the presence of low-dose ritonavir in healthy volunteers; and to compare the rate and extent of absorption of a single oral dose of 600 mg DRV administered as the suspension formulation F051 under fed conditions to that under fasted conditions, in the presence of low-dose ritonavir in healthy volunteers. In Part 2 we want to assess multiple dose pharmacokinetics of DRV administered as the suspension formulation F051 (under fed or fasted conditions, based on the results of Part 1), in the presence of low-dose ritonavir in healthy volunteers. The short-term safety and tolerability of DRV will be evaluated following administration of 3 single oral doses of 600 mg (formulated as suspension and as tablet) and following administration of multiple oral doses (formulated as suspension), all in presence of low-dose ritonavir in healthy volunteers Part 1: during 3 sessions volunteers will orally receive 3 single doses of 600 mg darunavir (DRV): 2 tablets of 300 mg and 6 ml of suspension under fed conditions and 6 mL of suspension (100 mg/mL) under fasted conditions on Day 3. Part 2: subjects will receive DRV suspension, twice daily from Day 1 to 6, with an additional morning dose on Day 7. In Part I rtv 100 mg will be coadministered twice daily from Day 1 to Day 5 and in Part 2 from Day 1 to Day 9.
  Eligibility

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoking, or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
  • Normal weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
  • Able to comply with protocol requirements. 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:

  • No positive HIV 1 or HIV 2 test at screening
  • no history of significant skin disease such as, but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria
  • no history of allergy to drugs such as, but not limited to, sulphonamides and penicillins
  • no previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial
  • no female subject of childbearing potential without use of effective nonhormonal birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
  • no positive pregnancy test or breast feeding at screening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752310


Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Limited Clinical Trial Tibotec Pharmaceutical Limited
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00752310     History of Changes
Other Study ID Numbers: CR012565
First Submitted: September 11, 2008
First Posted: September 15, 2008
Last Update Posted: June 9, 2011
Last Verified: April 2010

Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC114-TiDP29-C169
TMC114-C169
Darunavir (suspension formulation)

Additional relevant MeSH terms:
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents