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

• ClinicalTrials.gov Identifier: NCT03266705
• Recruitment Status: Completed
• First Posted: August 30, 2017
• Last Update Posted: May 14, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 28, 2017
• First Posted Date: August 30, 2017
• Last Update Posted Date: May 14, 2018
• Actual Study Start Date: September 20, 2017
• Actual Primary Completion Date: February 15, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2017)

• Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ]
• maximum observed plasma concentration (Cmax) [ Time Frame: 24 hours ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 28, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Drug: tafamidis

bioequivalence study

Study Arms

• Experimental: 61 mgA tafamidis free acid soft gelatin capsule
  Intervention: Drug: tafamidis
• Experimental: 4x20 mg tafamidis meglumine soft gelatin capsule
  Intervention: Drug: tafamidis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 28, 2017): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 1, 2018
• Actual Primary Completion Date: February 15, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03266705
• Other Study ID Numbers: B3461056; 2017-002572-15 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2018