NCT02746926

Brief Summary

3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 8 days. After another 14 days, the last formulation will be tested in the same way.

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

Timeline
Completed

Started Apr 2016

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

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 29, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

April 18, 2016

Last Update Submit

September 26, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time Curve (AUC)

    168 hours

  • Maximum Observed Plasma Concentration (Cmax)

    168 hours

Secondary Outcomes (4)

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

    168 hours

  • Mean residence time (MRT)

    168 hours

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    168 hours

  • Plasma Decay Half-Life (t1/2)

    168 hours

Study Arms (3)

4x20 mg tafamidis meglumine soft gel capsule

EXPERIMENTAL
Drug: tafamidis

48.8 mgA tafamidis free acid capsule

EXPERIMENTAL
Drug: tafamidis

61 mgA tafamidis free acid capsule

EXPERIMENTAL
Drug: tafamidis

Interventions

tafamidisDRUG
48.8 mgA tafamidis free acid capsule4x20 mg tafamidis meglumine soft gel capsule61 mgA tafamidis free acid capsule

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.
  • Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

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

April 18, 2016

First Posted

April 21, 2016

Study Start

April 29, 2016

Primary Completion

July 15, 2016

Study Completion

July 15, 2016

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

US(1)