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Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

Last updated on May 9, 2018

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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.
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

NCT01655511
Pfizer
Completed
Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

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Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
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
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
TTR Cardiomyopathy
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
September 2012
September 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01655511
B3461040
B3461040
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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