Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

TTR Cardiomyopathy Clinical Trial

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

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

• Cardiomyopathies
• TTR Cardiomyopathy

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

External Links

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