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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Maraviroc; Drug: PF-03716539; Drug: Darunavir + PF-03716539; Drug: Maraviroc +PF-03716539; Drug: Darunavir; Drug: Midazolam + PF-03716539 (100 mg); Other: Placebo; Drug: Midazolam; Drug: Midazolam + PF-03716539 (50 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783484

B0831001

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 6 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: PF-03716539

Drug: PF-03716539

Drug: PF-03716539

Drug: PF-03716539

Other: Placebo

Drug: PF-03716539

Drug: PF-03716539

Cohort 2

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: PF-03716539

Drug: PF-03716539

Drug: PF-03716539

Drug: PF-03716539

Other: Placebo

Drug: PF-03716539

Drug: PF-03716539

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Midazolam + PF-03716539 (50 mg)

Drug: Midazolam + PF-03716539 (100 mg)

Drug: Midazolam

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: Darunavir

Drug: Darunavir + PF-03716539

Cohort 5

Experimental group

Description:

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

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc +PF-03716539

Drug: Maraviroc +PF-03716539

Cohort 6

Experimental group

Description:

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

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc +PF-03716539

Drug: Maraviroc +PF-03716539