Drug Interaction Study Between Raltegravir And UK-453,061

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00784420
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: UK-453,061; Drug: UK-453,061; Drug: Raltegravir; Drug: Raltegravir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12 [11 days]

2. UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24 [11 days]

Secondary Outcome Measures

1. Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h [11 days]

2. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments [11 days]

3. UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h [11 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511-5473

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00784420
• Other Study ID Numbers: A5271019
• First Posted: Nov 4, 2008
• Last Update Posted: Nov 18, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: Drug Interaction, Pharmacokinetics
• Additional relevant MeSH terms: Raltegravir Potassium

Study Results

No Results Posted as of Nov 18, 2008