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NCT02697864 Clinical Trial

A Study Comparing Amounts of Tafamidis In The Blood Without Food

Healthy Clinical Trial

Official title:
A Phase 1, Open‑Label, Three Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf‑06291826 (Tafamidis) Free Acid Tablet Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02697864
Other study ID # B3461051
Secondary ID 2016-000295-16
Status Completed
Phase Phase 1
First received February 29, 2016
Last updated July 20, 2017
Start date April 2016
Est. completion date June 2016

Study information
Verified date July 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tafamidis

Locations
Country Name City State
Belgium Pfizer Clinical Research Unit Brussels

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the concentration-time Curve (AUC) 120 hours
Primary Maximum Observed Plasma Concentration (Cmax) 120 hours
Secondary Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 120 hours
Secondary Mean residence time (MRT) 120 hours
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) 120 hours
Secondary Plasma Decay Half-Life (t1/2) 120 hours
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