Drug Interaction Study Between Raltegravir And UK-453,061

Healthy Volunteers Clinical Trial

Official title:

Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784420
• Other study ID #: A5271019
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2008
• Last updated: November 17, 2008
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• UK-453,061
UK-453,061 1000 mg once daily for 10 days
• UK-453,061
UK-453,061 1000 mg once daily for 10 days
• Raltegravir
Raltegravir 400 mg twice daily for 10 days
• Raltegravir
Raltegravir 400 mg twice daily for 10 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12		11 days	No
Primary	UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24		11 days	No
Secondary	Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h		11 days	No
Secondary	Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments		11 days	No
Secondary	UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h		11 days	No

External Links

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