Drug Interaction Study Between Raltegravir And UK-453,061
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Purpose
The purpose of this study is to estimate the effect of steady state raltegravir on the steady state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state pharmacokinetics of raltegravir.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: UK-453,061 Drug: Raltegravir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects |
- Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12 [ Time Frame: 11 days ] [ Designated as safety issue: No ]
- UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24 [ Time Frame: 11 days ] [ Designated as safety issue: No ]
- Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h [ Time Frame: 11 days ] [ Designated as safety issue: No ]
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments [ Time Frame: 11 days ] [ Designated as safety issue: No ]
- UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h [ Time Frame: 11 days ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | September 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: UK-453,061 |
Drug: UK-453,061
UK-453,061 1000 mg once daily for 10 days
|
| Active Comparator: Raltegravir |
Drug: Raltegravir
Raltegravir 400 mg twice daily for 10 days
|
| Experimental: UK-453,061 plus Raltegravir |
Drug: UK-453,061
UK-453,061 1000 mg once daily for 10 days
Drug: Raltegravir
Raltegravir 400 mg twice daily for 10 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive; Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00784420 History of Changes |
| Other Study ID Numbers: | A5271019 |
| Study First Received: | September 30, 2008 |
| Last Updated: | November 17, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Drug Interaction, Pharmacokinetics |
ClinicalTrials.gov processed this record on June 18, 2013