Drug Interaction Study Between Raltegravir And UK-453,061

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00784420

Enrollment

Registered

2008-11-04

Start date

2008-09-30

Completion date

2008-11-30

Last updated

2008-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Drug Interaction, Pharmacokinetics

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.

Interventions

DRUGUK-453,061

UK-453,061 1000 mg once daily for 10 days

DRUGRaltegravir

Raltegravir 400 mg twice daily for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12	11 days
UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24	11 days

Secondary

Measure	Time frame
Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h	11 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments	11 days
UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h	11 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026