A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: tafamidis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03280173

B3461054

2017-002769-23 (EudraCT Number)

Details and patient eligibility

About

2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.

Enrollment: 18 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.
• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

61 mgA tafamidis free acid soft gelatin capsule fed

Experimental group

Description:

fasted

Treatment:

Drug: tafamidis

61 mgA tafamidis free acid soft gelatin capsule fasted

Experimental group

Description:

fed

Treatment:

Drug: tafamidis

4 × 20 mg tafamidis meglumine soft gelatin capsules fed

Experimental group

Description:

fed

Treatment:

Drug: tafamidis

4 × 20 mg tafamidis meglumine soft gelatin capsules fasted

Experimental group

Description:

fasted

Treatment:

Drug: tafamidis