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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00783484
First received: October 30, 2008
Last updated: May 28, 2009
Last verified: May 2009

October 30, 2008
May 28, 2009
October 2008
May 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects. [ Time Frame: 6 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783484 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • 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)
    Other Name: Selzentry
  • Drug: Maraviroc +PF-03716539
    Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)
    Other Name: Selzentry
  • Drug: Maraviroc
    Maraviroc 225 mg tablet once daily for 6 days (Days 1-6)
    Other Name: Selzentry
  • Drug: Maraviroc +PF-03716539
    Maraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7)
    Other Name: Selzentry
  • Experimental: Cohort 1
    PF-03716539 crossover, single dose escalation (doses subject to change).
    Interventions:
    • Drug: PF-03716539
    • Drug: PF-03716539
    • Drug: PF-03716539
    • Other: Placebo
  • Experimental: Cohort 2
    PF-03716539 crossover, single dose escalation (doses subject to change).
    Interventions:
    • Drug: PF-03716539
    • Drug: PF-03716539
    • Drug: PF-03716539
    • Other: Placebo
  • Experimental: Cohort 3
    Midazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
    Interventions:
    • Drug: Midazolam
    • Drug: Midazolam + PF-03716539 (100 mg)
    • Drug: Midazolam + PF-03716539 (50 mg)
  • Experimental: Cohort 4
    Darunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
    Interventions:
    • Drug: Darunavir
    • Drug: Darunavir + PF-03716539
  • Experimental: Cohort 5
    Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
    Interventions:
    • Drug: Maraviroc
    • Drug: Maraviroc +PF-03716539
  • Experimental: Cohort 6
    Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg).
    Interventions:
    • Drug: Maraviroc
    • Drug: Maraviroc +PF-03716539
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2009
May 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00783484
B0831001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP