A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood

Healthy Clinical Trial

Official title:

A Phase 1, Open-label, Randomized, Four-period, Four-sequence, Single-dose, Crossover Study In Healthy Volunteers, To Determine The Relative Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Compared To Commercial 4 × 20 Mg Tafamidis Meglumine Soft Gelatin Capsules Administered Under Fasted And Fed Conditions And The Effect Of Food On The Oral Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280173
• Other study ID #: B3461054
• Secondary ID: 2017-002769-23
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2017
• Last updated: April 5, 2018
• Start date: September 29, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: April 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• 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:

• 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.

• 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.

Related Conditions & MeSH terms

• Healthy

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	Area under the concentration-time curve 0-72 hours (AUC72)		72 hrs
Primary	maximum observed plasma concentration (Cmax)		168 hrs
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		168 hrs
Secondary	Mean residence time (MRT)		168 hrs
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		168 hrs
Secondary	Plasma Decay Half-Life (t1/2)		168 hrs
Secondary	Area under the curve from zero to infinity (AUCinf)		168 hrs

External Links

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