CompletedNCT03266705Updated May 14, 2018

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

A Phase 1 interventional study of tafamidis in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

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

Interventions

Drugtafamidis
bioequivalence study

What researchers measure

Primary outcomes

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

Secondary outcomes

minimum observed plasma concentration (Cmin)
Time frame: 24 hours
Time to maximum observed plasma concentration (Tmax)
Time frame: 24 hours

Study locations

1 site

Pfizer Clinical Research Unit
Brussels, B-1070, Belgium

References and documents

Individual participant data

Plan to share: No — 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

Registry details

Key details

Study ID: NCT03266705
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Aug 30, 2017
Start date: Sep 20, 2017
Primary completion: Feb 15, 2018
Completion: Mar 1, 2018
Last update: May 14, 2018

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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