NCT02217813

Brief Summary

Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

August 12, 2014

Last Update Submit

January 6, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Area under the Concentration-Time Curve (AUC)

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

    168 hours

  • Maximum Observed Plasma Concentration (Cmax)

    168 hours

Secondary Outcomes (4)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

    168 hours

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    168 hours

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    168 hours

  • Plasma Decay Half-Life (t1/2)

    168 hours

Study Arms (2)

1. Tafamidis

EXPERIMENTAL
Drug: Tafamidis

2. Tafamidis

EXPERIMENTAL
Drug: Tafamidis

Interventions

TafamidisDRUG

20 mg of current commercial formulation

Also known as: Vyndaqel
1. Tafamidis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females of non-child bearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110 lbs).

You may not qualify if:

  • 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 time of dosing).
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Interventions

tafamidis

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

BE(1)