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

Tracking Information

First Received Date ^ICMJE

July 12, 2012

Last Updated Date

September 26, 2012

Start Date ^ICMJE

July 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

• To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: Yes ]

Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination, vital signs, ECGs, and clinical laboratory tests.

Change History

Complete list of historical versions of study NCT01655511 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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 *

* 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

Enrollment ^ICMJE

Completion Date

September 2012

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

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT01655511

Other Study ID Numbers ^ICMJE

B3461040, B3461040

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2012

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

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