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Trial record 1 of 1 for:    NCT00783484
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A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT00783484
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : June 2, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 30, 2008
First Posted Date  ICMJE October 31, 2008
Last Update Posted Date June 2, 2009
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2008)
  • 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 ]
  • To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects. [ Time Frame: 6 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00783484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2008)
  • 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 ]
  • To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc. [ Time Frame: 8 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2009)
37
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2008)
32
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00783484
Other Study ID Numbers  ICMJE B0831001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2009

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