Clinical trial NCT01370343: Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Drug Interaction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Area under the plasma concentration versus time profile (AUC)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
measure: Max observed plasma concentration (Cmax)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Secondary outcomes:
measure: Time of Cmax (Tmax)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
measure: Terminal elimination half-life (t1/2)
timeFrame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
measure: Total amount of unchanged drug excreted in the urine over 24 hours (Ae24)
timeFrame: 0-8, and 8-24hr postdose
measure: Renal clearance (CLR)
timeFrame: 0-24hr
measure: Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24(% excreted))
timeFrame: 0-24hr
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: