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Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01655511
First received: July 12, 2012
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis


Condition Intervention Phase
TTR Cardiomyopathy
 Drug: Tafamidis
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination, [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: Yes ]
  • vital signs, ECGs, and clinical laboratory tests. [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax - Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ] [ Designated as safety issue: No ]
  • tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ] [ Designated as safety issue: No ]
  • AUC0-24 - AreArea under the Concentration-Time Curve (AUC) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ] [ Designated as safety issue: No ]
  • AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ] [ Designated as safety issue: No ]
  • AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ] [ Designated as safety issue: No ]
  • t½ - Plasma Decay Half-Life (t1/2) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ] [ Designated as safety issue: No ]
  • Transthyretin blood concentration in mg/dL [ Time Frame: Days 0,1,2,3,4,5,6 ] [ Designated as safety issue: No ]
  • Transthyretin stabilization (%) [ Time Frame: Days 0,1,2,3,4,5,6 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1
240 mg tafamidis arm
 Drug: Tafamidis
240 mg, solution, single dose
Experimental: Period 2
480 mg arm
 Drug: Tafamidis
480 mg, solution, single dose
Experimental: Period 3
TBD dose
 Drug: Tafamidis
TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655511

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01655511     History of Changes
Other Study ID Numbers: B3461040, B3461040
Study First Received: July 12, 2012
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacokinetic
pharmacodynamic

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013