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Completed

NCT Number: NCT02534740

A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food

This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tafamidis

Drug

relative bioavailability

Primary outcomes

  1. Area under the concentration-time Curve (AUC)

    Time frame: 120 hours

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 120 hours

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 120 hours

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 120 hours

  3. Plasma Decay Half-Life (t1/2)

    Time frame: 120 hours

  4. Area Under the Curve from Time zero to infinity

    Time frame: 120 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2015
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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