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
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Oct 2008
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJune 2, 2009
May 1, 2009
7 months
October 30, 2008
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
27 days
To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects.
6 days
Secondary Outcomes (2)
To assess the potency of PF 03716539 for CYP3A4 inhibition utilizing single dose IV midazolam as a probe substrate for CYP3A4/5.
6 days
To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc.
8 days
Study Arms (6)
Cohort 1
EXPERIMENTALPF-03716539 crossover, single dose escalation (doses subject to change).
Cohort 2
EXPERIMENTALPF-03716539 crossover, single dose escalation (doses subject to change).
Cohort 3
EXPERIMENTALMidazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
Cohort 4
EXPERIMENTALDarunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
Cohort 5
EXPERIMENTALMaraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
Cohort 6
EXPERIMENTALMaraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg).
Interventions
Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose
Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose
Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10)
Maraviroc 150 mg tablet once daily for 6 days (Days 1-6)
Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 2, 2009
Record last verified: 2009-05