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A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

NCT ID: NCT00783484

Last Updated: 2009-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

PF-03716539 crossover, single dose escalation (doses subject to change).

Group Type EXPERIMENTAL

PF-03716539

Intervention Type DRUG

PF-03716539 10 mg oral solution, single dose

PF-03716539

Intervention Type DRUG

PF-03716539 25 mg oral solution, single dose

PF-03716539

Intervention Type DRUG

PF-03716539 3 mg oral solution, single dose

Placebo

Intervention Type OTHER

Placebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose)

Cohort 2

PF-03716539 crossover, single dose escalation (doses subject to change).

Group Type EXPERIMENTAL

PF-03716539

Intervention Type DRUG

PF-03716539 100 mg oral solution, single dose

PF-03716539

Intervention Type DRUG

PF-03716539 200 mg oral solution, single dose

PF-03716539

Intervention Type DRUG

PF-03716539 50 mg oral solution, single dose

Placebo

Intervention Type OTHER

Placebo for 50 mg, 100 mg and 200 mg of PF-03716539 (single dose)

Cohort 3

Midazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Midazolam 1 mg IV, single dose

Midazolam + PF-03716539 (100 mg)

Intervention Type DRUG

Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose

Midazolam + PF-03716539 (50 mg)

Intervention Type DRUG

Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose

Cohort 4

Darunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

Darunavir 600 mg tablet twice daily for 9 days (Days 1-9)

Darunavir + PF-03716539

Intervention Type DRUG

Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10)

Cohort 5

Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

Maraviroc 150 mg tablet once daily for 6 days (Days 1-6)

Maraviroc +PF-03716539

Intervention Type DRUG

Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)

Cohort 6

Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg).

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

Maraviroc 225 mg tablet once daily for 6 days (Days 1-6)

Maraviroc +PF-03716539

Intervention Type DRUG

Maraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7)

Interventions

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PF-03716539

PF-03716539 10 mg oral solution, single dose

Intervention Type DRUG

PF-03716539

PF-03716539 25 mg oral solution, single dose

Intervention Type DRUG

PF-03716539

PF-03716539 3 mg oral solution, single dose

Intervention Type DRUG

Placebo

Placebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose)

Intervention Type OTHER

PF-03716539

PF-03716539 100 mg oral solution, single dose

Intervention Type DRUG

PF-03716539

PF-03716539 200 mg oral solution, single dose

Intervention Type DRUG

PF-03716539

PF-03716539 50 mg oral solution, single dose

Intervention Type DRUG

Placebo

Placebo for 50 mg, 100 mg and 200 mg of PF-03716539 (single dose)

Intervention Type OTHER

Midazolam

Midazolam 1 mg IV, single dose

Intervention Type DRUG

Midazolam + PF-03716539 (100 mg)

Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose

Intervention Type DRUG

Midazolam + PF-03716539 (50 mg)

Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose

Intervention Type DRUG

Darunavir

Darunavir 600 mg tablet twice daily for 9 days (Days 1-9)

Intervention Type DRUG

Darunavir + PF-03716539

Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10)

Intervention Type DRUG

Maraviroc

Maraviroc 150 mg tablet once daily for 6 days (Days 1-6)

Intervention Type DRUG

Maraviroc +PF-03716539

Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)

Intervention Type DRUG

Maraviroc

Maraviroc 225 mg tablet once daily for 6 days (Days 1-6)

Intervention Type DRUG

Maraviroc +PF-03716539

Maraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7)

Intervention Type DRUG

Other Intervention Names

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Selzentry Selzentry Selzentry Selzentry

Eligibility Criteria

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Inclusion Criteria

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight \>50 kg (110 lbs).

Exclusion Criteria

Pregnant or nursing females. females of childbearing potential. Evidence or history of clinically significant hematological, renal (including kidney stones), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at screening.

Treatment with an investigational drug within 30 days (or determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0831001&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20Single%20Oral%20Doses%20Of%20PF-03716539%20In%20Healthy%20Adult%20Subjects

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

Other Identifiers

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B0831001

Identifier Type: -

Identifier Source: org_study_id

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