A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State

NCT01690351 | Completed Phase 1

• 1 other identifier: B3291015
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

• Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)

  days 1-2

• AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)

  days 1-2

• AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)

  days 1-2

• Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)

  days 1-2

• t½ = Elimination half life of PF-05089771 (hr)

  days 1-2

Secondary Outcomes (1)

• evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.

  days 1-2

Study Arms (2)

PF-05089771 Oral Dispersion fasted

EXPERIMENTAL

Oral dispersion TS formulation- fasted

Drug: PF-05089771

PF-05089771 TS formulation fasted

EXPERIMENTAL

Capsules TS formulation- fasted

Drug: PF-05089771

Interventions

PF-05089771 DRUG

Oral dispersion TS formulation- fasted

PF-05089771 Oral Dispersion fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years

You may not qualify if:

• Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds \>120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

PF-05089771

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

BE (1)