NCT02406560

Brief Summary

Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions 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
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2015

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

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

March 30, 2015

Last Update Submit

August 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 (3)

  • 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 (3)

4 tablets of 12.2 mg tafamdis free acid

EXPERIMENTAL
Drug: tafamidis

4 tablets of 12.2 mg tafamidis free acid

EXPERIMENTAL
Drug: tafamidis

5 tablets of 12.2 mg tafamidis free acid

EXPERIMENTAL
Drug: tafamidis

Interventions

tafamidisDRUG

fasted

4 tablets of 12.2 mg tafamdis free acid

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

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

March 30, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

BE(1)