Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01370343
First received: June 8, 2011
Last updated: September 3, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Drug Interaction |
Drug: PF-04991532 alone Drug: PF-04991532 + cyclosporine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time of Cmax (Tmax) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose ] [ Designated as safety issue: No ]
- Terminal elimination half-life (t1/2) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose ] [ Designated as safety issue: No ]
- Total amount of unchanged drug excreted in the urine over 24 hours (Ae24) [ Time Frame: 0-8, and 8-24hr postdose ] [ Designated as safety issue: No ]
- Renal clearance (CLR) [ Time Frame: 0-24hr ] [ Designated as safety issue: No ]
- Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24(% excreted)) [ Time Frame: 0-24hr ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | July 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04991532 alone |
Drug: PF-04991532 alone
a single dose of 150 mg PF-04991532, fasted
|
| Experimental: PF-04991532 + cyclosporine |
Drug: PF-04991532 + cyclosporine
a single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01370343 History of Changes |
| Other Study ID Numbers: | B2611010 |
| Study First Received: | June 8, 2011 |
| Last Updated: | September 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013