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Transthyretin Stabilizer

Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed) for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168

Awards & highlights

Study Summary

The purpose of this clinical trial is to compare a tablet and a capsule form of tafamidis without food and to assess the amount of tafamidis in blood after taking the tablet form with food. This study is seeking healthy participants over the age of 18. All participants in the study will receive either one tablet or capsule of study medicine on the first day without food, then receive one dose of the other tablet or capsule form 16 days later without food. All participants will then receive one dose of the tablet form with food 16 days later. We will evaluate the amounts in blood for 8 days after taking each dose of the study medicine. Participants will take part in this study for about 96 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, eligible participants will visit the study clinic three times (and stay overnight in the clinical research center for 8 nights each time). The study team will also call participants over the phone 28 to 35 days after the last dose of medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the concentration-time curve (AUCinf)

Maximum observed plasma concentration (Cmax)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)Experimental Treatment2 Interventions

On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. Each period is separated by a washout of at least 16 days between administration of study drug.

Group II: Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tafamidis free acid tablet (Test)

2022

Completed Phase 1

~40

Tafamidis meglumine capsule (Reference)

2022

Completed Phase 1

~30

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,566 Previous Clinical Trials

10,907,901 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,473 Previous Clinical Trials

8,089,069 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for enrollment in this clinical trial?

"Affirmative. Perusal of the clinicaltrials.gov webpage presents that this research project, initially advertised on September 29th 2022, is currently recruiting for 22 participants from a single site. The trial was last updated on October 13th 2022."

Answered by AI

Are there still opportunities to participate in this clinical experiment?

"Yes, according to the information on clinicaltrials.gov this experiment is still open for enrolment. The posting was published at the end of September and recently edited in mid-October."

Answered by AI

Are there any health hazards associated with ingesting Test tablet on an empty stomach and then Reference capsule followed by a second dose of the Test tablet after eating?

"Due to a scarcity of evidence confirming the safety and efficacy, Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed) was scored with 1 on our team's scale that ranges from 1-3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Two Forms of Tafamidis Without Food and the Amount of Tafamidis in the Blood With Food

2022. "A Study Comparing Two Forms of Tafamidis Without Food and the Amount of Tafamidis in the Blood With Food". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05498701.