NCT02189330

Brief Summary

All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

May 15, 2014

Last Update Submit

July 14, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

    168 hours

  • Maximum Observed Plasma Concentration (Cmax)

    168 hours

Secondary Outcomes (2)

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

    168 hours

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    6

Study Arms (5)

Tafamidis

EXPERIMENTAL
Drug: Tafamidis

Tafamudus Free Acid

EXPERIMENTAL
Drug: Tafamidis

20 mg new soft gelatin capsule

EXPERIMENTAL
Drug: Tafamidis

4 capsules of 20 mg tafamidis of commercial formulation

EXPERIMENTAL
Drug: Tafamidis

4 capsules of 12.2 mg tafamidis of free acid tablet

EXPERIMENTAL
Drug: Tafamidis

Interventions

TafamidisDRUG

20 mg of current commercial formulation.

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 and total body weight more than 50 kg (110 lbs).

You may not qualify if:

  • Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
  • Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

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

May 15, 2014

First Posted

July 14, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

BE(1)