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

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00783484
Pfizer
Completed
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

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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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00783484
B0831001
No
Not Provided
Not Provided
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

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1-800-718-1021

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