Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826)

Healthy Volunteers Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-PERIOD, THREE-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN FASTED HEALTHY SUBJECTS, TO ASSESS THE SAFETY, PHARMACOKINETICS AND ORAL BIOAVAILABILITY OF TAFAMIDIS FREE ACID WET-MILLED SUSPENSION DOSES, RELATIVE TO 4 X 20 MG COMMERCIAL TAFAMIDIS MEGLUMINE CAPSULES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662191
• Other study ID #: B3461059
• Secondary ID: 2017-004935-35BA
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy males or females of non-child bearing potential.

• Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• 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 the study.

• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Tafamidis
bioavailability 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	1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)		0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
Primary	2. Maximum Observed Plasma Concentration (Cmax)		0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
Secondary	1. Area under the plasma concentration-time profile from time 0 to 24 hours post-dose (AUC24)		0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
Secondary	2. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)		0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
Secondary	3. Time to Reach Maximum Observed Plasma Concentration (Tmax)		0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

External Links

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