Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

NCT01655511

Last updated date
Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
TTR Cardiomyopathy
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, males or females, 21 to 55 years old.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

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


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 the
time of dosing).


Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment
with an investigational, prescription, or non-prescription drug

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Crossover, Ascending Dose-Tolerance Study To Assess The Safety And Pharmacokinetics Of Tafamidis Doses Greater Than 120 Mg As Oral Solution In Healthy Volunteers
Brief Summary This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
Detailed Description Not Provided
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: Basic Science
Condition  ICMJE TTR Cardiomyopathy
Intervention  ICMJE
  • Drug: Tafamidis
    240 mg, solution, single dose
  • Drug: Tafamidis
    480 mg, solution, single dose
  • Drug: Tafamidis
    TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
Study Arms  ICMJE
  • Experimental: Period 1
    240 mg tafamidis arm
    Intervention: Drug: Tafamidis
  • Experimental: Period 2
    480 mg arm
    Intervention: Drug: Tafamidis
  • Experimental: Period 3
    TBD dose
    Intervention: Drug: Tafamidis
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 30, 2012)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, males or females, 21 to 55 years old.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

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 the time of dosing).

Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug

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 NCT01655511
Other Study ID Numbers  ICMJE B3461040
B3461040
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 September 2012

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