- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01369277
A Single Dose Study In Japanese And Western Healthy Subjects To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-04991532
September 20, 2011 updated by: Pfizer
A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single Dose Escalation Study In Japanese Healthy Subjects, And Open Label, Single Dose Study In Western Healthy Subjects To Investigate The Safety, Tolerability, And Pharmacokinetics of PF-04991532.
This study is to investigate the safety, tolerability and pharmacokinetics of single ascending oral doses of PF-04991532 in Japanese healthy subjects.
The secondary objective is to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532 in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western healthy subjects.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Safety/Tolerability and Pharmacokinetics
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential, 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).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
- Japanese subjects must have four Japanese grandparents who were born in Japan.
- Mean body weight and the body weight range of Western subjects must be within ±10% of the Japanese subjects.
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 dosing).
- 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.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- 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.
- 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 or women of childbearing potential.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Japanese cohort
A total of 12 Japanese healthy subjects will be allocated to receive 3 ascending single doses (100 mg, 300 mg and 750 mg) of PF-04991532 or placebo through 3 dosing periods in a randomization ratio of 3:1.
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Single dose administration of PF-04991532 (100 mg, 300 mg and 750 mg) in tablet formulation under fasted condition.
Single dose administration of matching placebo in tablet formulation at the fasted state
Single dose administration of PF-04991532 (300 mg and 750 mg) in tablet formulation under fasted condition.
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EXPERIMENTAL: Weterner Cohort
9 western healthy subjects will be enrolled to receive 2 single ascending doses (300 mg and 750 mg) of PF-04991532 through 2 dosing periods.
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Single dose administration of PF-04991532 (100 mg, 300 mg and 750 mg) in tablet formulation under fasted condition.
Single dose administration of PF-04991532 (300 mg and 750 mg) in tablet formulation under fasted condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours post dose
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Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours post dose
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Time for Cmax (Tmax)
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
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Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
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Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
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Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
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Area under the plasma concentration-time profile from time zero to 24 hours (AUC0-24)
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
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Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
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Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24%)
Time Frame: Urine collection from 0 to 24 hours post dose
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Urine collection from 0 to 24 hours post dose
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Renal clearance (CLr)
Time Frame: Urine collection from 0 to 24 hours post dose
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Urine collection from 0 to 24 hours post dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
June 7, 2011
First Submitted That Met QC Criteria
June 7, 2011
First Posted (ESTIMATE)
June 8, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 22, 2011
Last Update Submitted That Met QC Criteria
September 20, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Metabolic Diseases
- Glucose Metabolism Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Micronutrients
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Other Study ID Numbers
- B2611013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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