A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tafamidis

• Registration Number: NCT02189330
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tafamidis	Tafamidis	-
4 capsules of 20 mg tafamidis of commercial formulation	Tafamidis	-
20 mg new soft gelatin capsule	Tafamidis	-
4 capsules of 12.2 mg tafamidis of free acid tablet	Tafamidis	-
Tafamudus Free Acid	Tafamidis	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	168 hours	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).
Maximum Observed Plasma Concentration (Cmax)	168 hours

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	168 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Brussels, Belgium