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NCT Number: NCT00783484

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-03716539

Drug

PF-03716539 10 mg oral solution, single dose

Placebo

Other

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

midazolam

Drug

Midazolam 1 mg IV, single dose

Midazolam + PF-03716539 (100 mg)

Drug

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

Midazolam + PF-03716539 (50 mg)

Drug

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

Darunavir

Drug

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

Darunavir + PF-03716539

Drug

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

Maraviroc

Drug

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

Other names: Selzentry

Maraviroc +PF-03716539

Drug

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

Other names: Selzentry

Primary outcomes

  1. To evaluate the safety and tolerability of escalating single oral doses of PF 03716539 administered as Extemporaneous Powder for Solution (EPS) in healthy adult subjects.

    Time frame: 27 days

  2. To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects.

    Time frame: 6 days

Secondary outcomes

  1. To assess the potency of PF 03716539 for CYP3A4 inhibition utilizing single dose IV midazolam as a probe substrate for CYP3A4/5.

    Time frame: 6 days

  2. To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc.

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double-Blind (3rd Party Open), Placebo-Controlled, Crossover, Dose Escalating Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539, To Assess The Potential Of PF-03716539 To Inhibit CYP3A4 (In Vivo) And To Evaluate The Drug Interaction Potential Between PF-03716539 And Darunavir Or Maraviroc In Healthy Adult Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2008
Registry last updated
Jun 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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