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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01655511
Other study ID # B3461040
Secondary ID B3461040
Status Completed
Phase Phase 1
First received July 12, 2012
Last updated September 26, 2012
Start date July 2012
Est. completion date September 2012

Study information

Verified date September 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Tafamidis
240 mg, solution, single dose
Tafamidis
480 mg, solution, single dose
Tafamidis
TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.

Locations

Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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, Day 0 and Day 6 Yes
Primary vital signs, ECGs, and clinical laboratory tests. Day 0 and Day 6 Yes
Secondary Cmax - Maximum Observed Plasma Concentration (Cmax) 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs No
Secondary tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax) 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs No
Secondary AUC0-24 - AreArea under the Concentration-Time Curve (AUC) 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs No
Secondary AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs No
Secondary AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs No
Secondary t½ - Plasma Decay Half-Life (t1/2) 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs No
Secondary Transthyretin blood concentration in mg/dL Days 0,1,2,3,4,5,6 No
Secondary Transthyretin stabilization (%) Days 0,1,2,3,4,5,6 No
See also
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Completed NCT01775761 - A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc) Phase 1