A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: tafamidis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02534740

2015-002315-15 (EudraCT Number)

B3461052

Details and patient eligibility

About

This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose 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. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.

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 5 patient groups

4 soft gel capsules of 20 mg tafamidis meglumine

Experimental group

Treatment:

Drug: tafamidis

Drug: tafamidis

Drug: tafamidis

48.8 mg tafamidis soft gel capsule formulation 1

Experimental group

Treatment:

Drug: tafamidis

Drug: tafamidis

Drug: tafamidis

48.8 mg tafamidis soft get capsule formulation 2

Experimental group

Treatment:

Drug: tafamidis

Drug: tafamidis

Drug: tafamidis

61 mg tafamidis soft gel capsule formulation 1

Experimental group

Treatment:

Drug: tafamidis

Drug: tafamidis

Drug: tafamidis

61 mg tafamidis soft gel capsule formulation 2

Experimental group

Treatment:

Drug: tafamidis

Drug: tafamidis

Drug: tafamidis