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Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

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NCT02871037

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-254-6398
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Normal Healthy
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 males and female of non-childbearing potential;

- Body Mass Index 17.5-30.5 kg/m2;

- Body weight >50 kg;

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

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

NCT02871037
Pfizer
Completed
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

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Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
A Phase 1, 3-part Study Of Pf-05221304 In Healthy Adults: Part 1 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Single, Escalating, Oral Doses; Part 2 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Repeated, Escalating, Oral Doses; Conditional Part 3 - Effect Of Food On The Pharmacokinetics Of Pf-05221304
The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Normal Healthy
  • Drug: PF-05221304
    Single or repeated, escalating dose of PF-05221304
  • Other: Placebo
    single or repeated dose of placebo
  • Experimental: Part 1_Cohort 1_Active
    Single, escalating dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Part 1_Cohort 1_Placebo
    Single dose of Placebo
    Intervention: Other: Placebo
  • Experimental: Part 1_Cohort 2_Active
    Single, escalating dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Part 1_Cohort 2_Placebo
    Single dose of Placebo
    Intervention: Other: Placebo
  • Experimental: Part 2_Active
    Repeated, escalating doses of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Part 2_Placebo
    Repeated doses of placebo
    Intervention: Other: Placebo
  • Experimental: Part 3
    Single dose of PF-05221304 with and without food
    Intervention: Drug: PF-05221304
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
March 27, 2017
March 27, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males and female of non-childbearing potential;
  • Body Mass Index 17.5-30.5 kg/m2;
  • Body weight >50 kg;

Exclusion Criteria:

  • Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02871037
C1171001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

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.

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1-800-718-1021

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[email protected]



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