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A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

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NCT01064492

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female 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.

- Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- A positive urine drug screen.

NCT01064492
Pfizer
Completed
A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

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[email protected]

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A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
Drug: PF-04620110
The three treatments are A) a single dose of 5 mg PIC under fasted condition; B) a single dose of 5 mg tablet under fasted condition: and C) a single dose of 5 mg tablet under fed condition.
Experimental: ABC, ACB, BAC, BCA, CAB, and CBA
Intervention: Drug: PF-04620110
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female 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.
  • Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01064492
B0961004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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