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First-In-Human Study Of PF-04958242 In Healthy Volunteers

Last updated on March 31, 2020

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
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
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy volunteers, male and female, ages 21-55

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

- No women of child-bearing potential, no risk factors for seizures, no risk factors for
QTc prolongation

NCT01159483
Pfizer
Completed
First-In-Human Study Of PF-04958242 In Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE First-in-Human Study of PF-04958242 in Healthy Volunteers
Official Title  ICMJE A Phase I, First-in-Human, Randomized, Subject and Investigator-Blind, Sponsor Open, Single Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pf-04958242 in Healthy Adult Volunteers
Brief Summary The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating doses of PF-04958242 administered orally to healthy adult participants.
Detailed Description This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: PF-04958242
    Administered as specified in the treatment arm
  • Drug: Placebo
    Administered as specified in the treatment arm
Study Arms  ICMJE
  • Experimental: Cohort A

    Period 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally.

    Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally.

    Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally.

    Interventions:
    • Drug: PF-04958242
    • Drug: Placebo
  • Experimental: Cohort B

    Period 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted).

    Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally.

    Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed).

    Interventions:
    • Drug: PF-04958242
    • 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: July 7, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 16, 2010
Actual Primary Completion Date October 16, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
  • Total body weight >50 kilograms (kg) (110 pounds [lbs]);

Key Exclusion Criteria:

  • Evidence or 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);
  • Positive urine drug screen;
  • Pregnant or nursing females, and females of child bearing potential;
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159483
Other Study ID Numbers  ICMJE B1701001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date December 2019

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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