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Completed

NCT Number: NCT03662191

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

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.

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Key information

Conditions

Healthy Volunteers

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

  • 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.

Treatment and study plan

Tafamidis

Drug

bioavailability study

Primary outcomes

  1. 1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

  2. 2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

Secondary outcomes

  1. 1. Area under the plasma concentration-time profile from time 0 to 24 hours post-dose (AUC24)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

  2. 2. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

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

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Feb 11, 2019

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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