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Completed

NCT Number: NCT03280173

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

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.

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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

bioavailability study

Primary outcomes

  1. Area under the concentration-time curve 0-72 hours (AUC72)

    Time frame: 72 hrs

  2. maximum observed plasma concentration (Cmax)

    Time frame: 168 hrs

Secondary outcomes

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

    Time frame: 168 hrs

  2. Mean residence time (MRT)

    Time frame: 168 hrs

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

    Time frame: 168 hrs

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

    Time frame: 168 hrs

  5. Area under the curve from zero to infinity (AUCinf)

    Time frame: 168 hrs

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Apr 6, 2018

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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