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

Summary

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.

Conditions

• Healthy Volunteers

Interventions

DRUG

PF-03716539

PF-03716539 10 mg oral solution, single dose

DRUG

PF-03716539

PF-03716539 25 mg oral solution, single dose

DRUG

PF-03716539

PF-03716539 3 mg oral solution, single dose

OTHER

Placebo

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

DRUG

PF-03716539

PF-03716539 100 mg oral solution, single dose

DRUG

PF-03716539

PF-03716539 200 mg oral solution, single dose

DRUG

PF-03716539

PF-03716539 50 mg oral solution, single dose

OTHER

Placebo

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

DRUG

Midazolam

Midazolam 1 mg IV, single dose

DRUG

Midazolam + PF-03716539 (100 mg)

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

DRUG

Midazolam + PF-03716539 (50 mg)

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

DRUG

Darunavir

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

DRUG

Darunavir + PF-03716539

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

DRUG

Maraviroc

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

DRUG

Maraviroc +PF-03716539

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

DRUG

Maraviroc

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

DRUG

Maraviroc +PF-03716539

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

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• Belgium

Study Locations