Single Dose Study of PF-05230907 in Healthy Japanese Subjects

NCT02537002

Last updated date
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511-5473, United States
Contact
1-800-718-1021

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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
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male of females

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).

- Japanese subjects who have four biologic Japanese grandparents born in Japan.

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


- Pregnant or nursing females.


- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception.


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Single Dose Study of PF-05230907 in Healthy Japanese Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects
Brief Summary

The purpose of this study is the following:

  • To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
  • To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
  • To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
  • To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-05230907
    A single intravenous dose of 3 ?g/kg
  • Drug: PF-05230907
    A single intravenous dose of 5 ?g/kg
  • Drug: Placebo
    A single intravenous dose of matched placebo
Study Arms  ICMJE
  • Experimental: Cohort 1- PF-05230907 or Placebo
    Interventions:
    • Drug: PF-05230907
    • Drug: Placebo
  • Experimental: Cohort 2- PF-05230907 or Placebo
    Interventions:
    • Drug: PF-05230907
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2016)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
12
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male of females
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
  • Japanese subjects who have four biologic Japanese grandparents born in Japan.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537002
Other Study ID Numbers  ICMJE B2341003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP