Relative Bioavailability Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01602887
First received: May 17, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

This is a BA study comparing the bioavailability of two new capsule formulations and one solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: PD-0332991
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single Dose Open-Label Relative Bioavailability Study Comparing Two Capsule And A Solution Formulation Of PD-0332991 To The PD-0332991 Isethionate Capsule In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma AUCinf for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Cmax for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma AUClast for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Tmax for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma t1/2 for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma CL/F for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Vz/F for PD-0332991 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma AUClast for PF-05089326 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma AUCinf for PF-05089326 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Cmax for PF-05089326 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Tmax for PF-05089326 [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma AUClast for PF 05089326 / PD-0332991 ratio if appropriate [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma AUCinf for PF 05089326 / PD-0332991 ratio if appropriate [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Cmax for PF 05089326 / PD-0332991 ratio if appropriate [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Tmax for PF 05089326 / PD-0332991 ratio if appropriate [ Time Frame: 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference
This is the reference formulation
Drug: PD-0332991
isethionate hard capsule, 125 mg, single dose
Experimental: NF1
This is a test formulation
Drug: PD-0332991
freebase hard capsule with a "small" particle size, 125 mg, single dose
Experimental: NF2
This is a test formulation
Drug: PD-0332991
freebase hard capsule with a "large" particle size, 125 mg, single dose
Experimental: SOL
This is a test formulation
Drug: PD-0332991
oral solution, 50 mg, single dose

  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 subjects. 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 or clinical laboratory tests.
  • 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 legal representative, as applicable.
  • Subjects who are willing and able to comply with all 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, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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 30 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 greater than or equal to140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), on a single measurement per local SOP.
  • 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, 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.
  • Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of less than or equal to1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602887

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01602887     History of Changes
Other Study ID Numbers: A5481009
Study First Received: May 17, 2012
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
BA/BE
PK
PD-0332991
PF-05089326
Breast Cancer

ClinicalTrials.gov processed this record on April 22, 2014