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

• ClinicalTrials.gov Identifier: NCT02189330
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: July 15, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: Tafamidis	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions
• Study Start Date: May 2014
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tafamidis	Drug: Tafamidis; 20 mg of current commercial formulation.
Experimental: Tafamudus Free Acid	Drug: Tafamidis; 12.2 mgA free acid tablet.
Experimental: 20 mg new soft gelatin capsule	Drug: Tafamidis; 20 mg new soft gelatin capsule.
Experimental: 4 capsules of 20 mg tafamidis of commercial formulation	Drug: Tafamidis; 4 capsules of 20 mg tafamidis of current commercial formulation.
Experimental: 4 capsules of 12.2 mg tafamidis of free acid tablet	Drug: Tafamidis; 4 capsules of 12.2 mg tafamidis of free acid tablet..

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 168 hours ]
   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 6 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Belgium

Pfizer Investigational Site

Brussels, Belgium, B-1070

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02189330
• Other Study ID Numbers: B3461030
• First Posted: July 14, 2014
• Last Update Posted: July 15, 2014
• Last Verified: July 2014