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A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

Last updated on October 9, 2018

FOR MORE INFORMATION
Study Location
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subjects who, at the time of screening, are between the ages of
20 and 55 years, inclusive.

- Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg
(110 lb).

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, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing) or clinical findings at Screening.

NCT03597217
Pfizer
Recruiting
A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

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A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults
A Phase 1, 2-part Study of PF-05221304 in Healthy Japanese Adults: Part 1 - Randomized, Double-blind, Crossover, Single Dose Assessment of Pharmacokinetics and Safety; Part 2- Randomized, Double-blind, Placebo-controlled, Multiple Dose Assessment of Safety, Tolerability and Pharmacokinetics of PF-05221304
The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05221304
    3, 10, 50 mg
  • Drug: PF-05221304
    50 mg multiple dose
  • Drug: Placebo
    Placebo
  • Experimental: Cohort A_Active
    3 single doses treatment of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort B_Active
    Repeated doses of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Cohort B_Placebo
    Repeated doses of placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
Same as current
November 15, 2018
November 15, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
  • Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.
Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03597217
C1171013
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

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

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[email protected]



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