A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Healthy Adult Subjects

Pfizer1 site in 1 country12 target enrollmentJuly 2011

ConditionsHealthy Drug Interaction

InterventionsPF-04991532 alone PF-04991532 + cyclosporine

DrugsPF-04991532 alone PF-04991532 + cyclosporine

Overview

Phase: Phase 1
Intervention: PF-04991532 alone
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 12
Locations: 1
Primary Endpoint: Area under the plasma concentration versus time profile (AUC)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
•An informed consent document signed and dated by the subject or a legally acceptable representative.
•Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, sychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
•Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), or evidence of any infection within the past 7 days.
•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.

Arms & Interventions

PF-04991532 alone

Intervention: PF-04991532 alone

PF-04991532 + cyclosporine

Intervention: PF-04991532 + cyclosporine

Outcomes

Primary Outcomes

Area under the plasma concentration versus time profile (AUC)

Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose

Max observed plasma concentration (Cmax)

Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose

Secondary Outcomes

Time of Cmax (Tmax)(predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose)
Terminal elimination half-life (t1/2)(predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose)
Total amount of unchanged drug excreted in the urine over 24 hours (Ae24)(0-8, and 8-24hr postdose)
Renal clearance (CLR)(0-24hr)
Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24(% excreted))(0-24hr)