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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tafamidis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02189330

B3461030

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

Tafamidis

Experimental group

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Tafamudus Free Acid

Experimental group

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

20 mg new soft gelatin capsule

Experimental group

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

4 capsules of 20 mg tafamidis of commercial formulation

Experimental group

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

4 capsules of 12.2 mg tafamidis of free acid tablet

Experimental group

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis