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

Healthy Clinical Trial

Official title:

A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266705
• Other study ID #: B3461056
• Secondary ID: 2017-002572-15
• Status: Completed
• Phase: Phase 1
• Start date: September 20, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• tafamidis
bioequivalence study

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC)		24 hours
Primary	maximum observed plasma concentration (Cmax)		24 hours
Secondary	minimum observed plasma concentration (Cmin)		24 hours
Secondary	Time to maximum observed plasma concentration (Tmax)		24 hours

External Links

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