NCT01369836

Brief Summary

The purpose of this study is the following:

  • To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
  • To compare Japanese and Western PK profiles.
  • Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 healthy

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

June 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

June 6, 2011

Last Update Submit

September 12, 2011

Conditions

Healthy

Keywords

TafamidisPharmacokineticsTTR stabilization

Outcome Measures

Primary Outcomes (4)

  • Plasma concentration of tafamidis over time (AUClast).

    2 months

  • Plasma concentration of tafamidis over time (Cmax).

    2 months

  • Plasma concentration of tafamidis over time (Tmax).

    2 months

  • If data permit, AUCinf and t1/2 will be determined.

    2 months

Secondary Outcomes (1)

  • The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.

    2 months

Study Arms (3)

20 mg soft gelatin capsule

EXPERIMENTAL
Drug: Tafamidis meglumin

40 mg (20 mg*2) soft gelatin capsule

EXPERIMENTAL
Drug: Tafamidis meglumin

Placebo

ACTIVE COMPARATOR
Drug: Placebo

Interventions

Tafamidis megluminDRUG

A single oral dose of 20 mg capsule

Also known as: PF-06291826
20 mg soft gelatin capsule
PlaceboDRUG

A single oral dose of matched placebo.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male or females.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

You may not qualify if:

  • Pregnant or nursing females.
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 9, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

US(1)