A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: tafamidis

• Registration Number: NCT03266705
• Lead Sponsor: Pfizer

Brief Summary

2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2017-09-20
• Primary Completion: 2018-02-15
• Study Completion: 2018-03-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy males of females of non-childbearing potential
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

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.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4x20 mg tafamidis meglumine soft gelatin capsule	tafamidis	-
61 mgA tafamidis free acid soft gelatin capsule	tafamidis	-

Primary Outcome Measures

Name	Time	Method
maximum observed plasma concentration (Cmax)	24 hours
Area under the concentration-time curve (AUC)	24 hours

Secondary Outcome Measures

Name	Time	Method
minimum observed plasma concentration (Cmin)	24 hours
Time to maximum observed plasma concentration (Tmax)	24 hours

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium