NCT00784420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
Last Updated

November 18, 2008

Status Verified

November 1, 2008

Enrollment Period

2 months

First QC Date

September 30, 2008

Last Update Submit

November 17, 2008

Conditions

Healthy Volunteers

Keywords

Drug Interaction, Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12

    11 days

  • UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24

    11 days

Secondary Outcomes (3)

  • 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

Study Arms (3)

UK-453,061

ACTIVE COMPARATOR
Drug: UK-453,061

Raltegravir

ACTIVE COMPARATOR
Drug: Raltegravir

UK-453,061 plus Raltegravir

EXPERIMENTAL
Drug: UK-453,061Drug: Raltegravir

Interventions

UK-453,061DRUG

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

UK-453,061 plus Raltegravir
RaltegravirDRUG

Raltegravir 400 mg twice daily for 10 days

Raltegravir

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

MeSH Terms

Interventions

UK 453,061Raltegravir Potassium

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2008

First Posted

November 4, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 18, 2008

Record last verified: 2008-11

Locations

US(1)