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Multiple Dose Tolerance Study For PF-04958242

Last updated on March 26, 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

- males or females of non-childbearing capacity

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

- No medical, neurological or psychiatric illness

NCT01238679
Pfizer
Terminated
Multiple Dose Tolerance Study For PF-04958242

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Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
Official Title  ICMJE A Phase I, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple 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 evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.
Detailed Description

A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.

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: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
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 1
    Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 2
    Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 3
    Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 4
    Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 5
    Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 6
    Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.
    Intervention: Drug: PF-04958242
  • Placebo Comparator: Matching Placebo
    Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.
    Intervention: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 7, 2011)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2010)
40
Actual Study Completion Date  ICMJE May 3, 2011
Actual Primary Completion Date May 3, 2011   (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 NCT01238679
Other Study ID Numbers  ICMJE B1701002
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

BY EMAIL

Contact

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