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First in Human Study for PF-06667272

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
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
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 allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)

NCT03126149
Pfizer
Not yet recruiting
First in Human Study for PF-06667272

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Descriptive Information
Brief Title  ICMJE First in Human Study for PF-06667272
Official Title  ICMJE A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects
Brief SummaryThe current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06667272
    Single ascending dose of PF-06667272
  • Other: Placebo
    Single dose of placebo
Study Arms  ICMJE
  • Experimental: Cohort 1_Period 1_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 1_Period 1_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohort 1_Period 2_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 1_Period 2_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohort 1_Period 3_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 1_Period 3_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohrot 1_Period 4_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 1_Period 4_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohort 2_Period 1_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 2_Period 1_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohort 2_Period 2_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 2_Period 2_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohort 2_Period 3_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 2_Period 3_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Cohort 2_Period 4_Active
    Single ascending dose of PF-06667272
    Intervention: Drug: PF-06667272
  • Placebo Comparator: Cohort 2_Period 4_Placebo
    Single dose of placebo
    Intervention: Other: 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 19, 2017)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 5, 2017
Actual Primary Completion DateSeptember 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03126149
Other Study ID Numbers  ICMJE C0231002
2017-000590-36 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2017

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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