Study To Estimate The Relative Bioavailability of PF-04971729 in Healthy Adult Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01114568
First received: April 27, 2010
Last updated: June 28, 2010
Last verified: June 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to examine the rate and extent of absorption of three oral formulations of PF 04971729 administered in lean to obese healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF 04971729 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04971729 in Lean To Obese, Otherwise Healthy Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life [ Time Frame: 1 week (i.e. 3 x 48 hours) ] [ Designated as safety issue: No ]
- Safety Endpoints: assessed by physical examinations, adverse event monitoring, fluid balance, 12 lead ECGs, vital sign, and clinical laboratory measurements [ Time Frame: 1 month (actually 3 x 1 week + 2 days) ] [ Designated as safety issue: Yes ]
- Pharmacodynamic Endpoints: Time course of the urinary glucose excretion over the intervals of 0 4 hour, 4 8 hour, 8 12 hour, 12 24 hour, 24 36 hour and 36 48 hour postdose. [ Time Frame: 1 week (i.e. 3 x 48 hours) ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | May 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 3-period, 6 sequence crossover study
The three formulations A), B) and C) will be administered as sequence: ABC, ACB, BAC, BCA, CAB and CBA
|
Drug: PF 04971729
Formulation A) PF 04971729 10 mg - administered as tablet
Drug: PF 04971729
Formulation B) PF 04971729 10 mg - administered as capsule
Drug: PF 04971729
Formulation C) PF 04971729 10 mg - administered as capsule
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 21 and 65 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
- Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- 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, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen at Screening or prior to dosing in Period 1.
- 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.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01114568 History of Changes |
| Other Study ID Numbers: | B1521005 |
| Study First Received: | April 27, 2010 |
| Last Updated: | June 28, 2010 |
| Health Authority: | Singapore: Singapore Health Sciences Authority (HSA) |
Keywords provided by Pfizer:
|
Relative Bioavailability Pharmacokinetics Pharmacodynamics |
ClinicalTrials.gov processed this record on May 23, 2013