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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03266705
• Date of registration: 28/08/2017
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
• Scientific 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
• Date of first enrolment: September 20, 2017
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03266705
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: tafamidis

Primary Outcome(s)

Area under the concentration-time curve (AUC) [Time Frame: 24 hours]

maximum observed plasma concentration (Cmax) [Time Frame: 24 hours]

Secondary Outcome(s)

minimum observed plasma concentration (Cmin) [Time Frame: 24 hours]

Time to maximum observed plasma concentration (Tmax) [Time Frame: 24 hours]

Secondary ID(s)

2017-002572-15

B3461056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors