A Study Comparing Amounts of Tafamidis In The Blood Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: tafamidis

• Registration Number: NCT02697864
• Lead Sponsor: Pfizer

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-03
• Study Start: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
58 mgA tafamidis free acid tablet	tafamidis	-
48.8 mgA tafamidis free acid tablet	tafamidis	-
4 soft gel capsules of 20 mg tafamidis meglumine	tafamidis	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time Curve (AUC)	120 hours
Maximum Observed Plasma Concentration (Cmax)	120 hours

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	120 hours
Mean residence time (MRT)	120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)	120 hours
Plasma Decay Half-Life (t1/2)	120 hours

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium