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

NCT03266705 | Completed Phase 1 FDA Drug

• 2 other identifiers: B34610562017-002572-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve (AUC)

  24 hours

• maximum observed plasma concentration (Cmax)

  24 hours

Secondary Outcomes (2)

• minimum observed plasma concentration (Cmin)

  24 hours

• Time to maximum observed plasma concentration (Tmax)

  24 hours

Study Arms (2)

61 mgA tafamidis free acid soft gelatin capsule

EXPERIMENTAL

Drug: tafamidis

4x20 mg tafamidis meglumine soft gelatin capsule

EXPERIMENTAL

Drug: tafamidis

Interventions

tafamidis DRUG

bioequivalence study

4x20 mg tafamidis meglumine soft gelatin capsule; 61 mgA tafamidis free acid soft gelatin capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

tafamidis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: September 20, 2017
• Primary Completion: February 15, 2018
• Study Completion: March 1, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)