ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03280173
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: tafamidis Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 61 mgA tafamidis free acid soft gelatin capsule fed
fasted
Drug: tafamidis
bioavailability study

Experimental: 61 mgA tafamidis free acid soft gelatin capsule fasted
fed
Drug: tafamidis
bioavailability study

Experimental: 4 × 20 mg tafamidis meglumine soft gelatin capsules fed
fed
Drug: tafamidis
bioavailability study

Experimental: 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted
fasted
Drug: tafamidis
bioavailability study




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280173


Locations
Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03280173     History of Changes
Other Study ID Numbers: B3461054
2017-002769-23 ( EudraCT Number )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes