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Trial record 1 of 1 for:    NCT02537002
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Single Dose Study of PF-05230907 in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT02537002
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-05230907 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Cohort 1- PF-05230907 or Placebo Drug: PF-05230907
A single intravenous dose of 3 μg/kg

Drug: Placebo
A single intravenous dose of matched placebo

Experimental: Cohort 2- PF-05230907 or Placebo Drug: PF-05230907
A single intravenous dose of 5 μg/kg

Drug: Placebo
A single intravenous dose of matched placebo




Primary Outcome Measures :
  1. Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907 [ Time Frame: up to 2 months ]

Secondary Outcome Measures :
  1. Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  2. Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  3. Single dose Plasma Decay Half-Life (t1/2) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  4. Single dose steady state Volume of Distribution (Vss) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  5. Single dose clearance (CL) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  6. Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  7. Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  8. Change of aPTT from pre-dose to post-dose [ Time Frame: Hour 0, 24 hour post-dose ]
  9. Change of prothrombin fragments 1+2 (PF1+2) [ Time Frame: Hour 0, 24 hour post-dose ]
  10. Change of plasma D-dimer [ Time Frame: Hour 0, 48 hour post-dose ]
  11. Incidence of development of anti-drug antibody (ADA) [ Time Frame: up to 2 months ]
  12. Incidence of development of neutralizing antibody (NAb) [ Time Frame: up to 2 months ]
  13. Change of factor X activity [ Time Frame: up to 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537002


Locations
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United States, Connecticut
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02537002    
Other Study ID Numbers: B2341003
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by Pfizer:
PF-05230907
Pharmacokinetics
Pharmacodynamic
Immunogenicity