A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults

NCT06273839 | Completed Phase 1 FDA Drug

• 2 other identifiers: B34611142023-509241-12-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking three different forms of tafamidis by mouth.

Conditions

Healthy

Keywords

tafamidis

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve (AUCinf)

  Area under the plasma concentration time profile from time zero extrapolated to infinite time

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

• Maximum observed plasma concentration (Cmax)

  Peak or maximum observed concentration

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

Study Arms (6)

Test 1 tablet followed by Test 2 tablet followed by Reference capsule

EXPERIMENTAL

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

Drug: Tafamidis 61 mg free acid tablet (Test 1); Drug: Tafamidis 70 mg free acid tablet (Test 1); Drug: Tafamidis 61 mg free acid capsule (Reference)

Test 1 tablet followed by Reference capsule followed by Test 2 tablet

EXPERIMENTAL

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

Drug: Tafamidis 61 mg free acid tablet (Test 1); Drug: Tafamidis 70 mg free acid tablet (Test 1); Drug: Tafamidis 61 mg free acid capsule (Reference)

Test 2 tablet followed by Reference capsule followed by Test 1 tablet

EXPERIMENTAL

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

Drug: Tafamidis 61 mg free acid tablet (Test 1); Drug: Tafamidis 70 mg free acid tablet (Test 1); Drug: Tafamidis 61 mg free acid capsule (Reference)

Test 2 tablet followed by Test 1 tablet followed by Reference capsule

EXPERIMENTAL

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

Drug: Tafamidis 61 mg free acid tablet (Test 1); Drug: Tafamidis 70 mg free acid tablet (Test 1); Drug: Tafamidis 61 mg free acid capsule (Reference)

Reference capsule followed by Test 1 tablet followed by Test 2 tablet

EXPERIMENTAL

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

Drug: Tafamidis 61 mg free acid tablet (Test 1); Drug: Tafamidis 70 mg free acid tablet (Test 1); Drug: Tafamidis 61 mg free acid capsule (Reference)

Reference capsule followed by Test 2 tablet followed by Test 1 tablet

EXPERIMENTAL

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

Drug: Tafamidis 61 mg free acid tablet (Test 1); Drug: Tafamidis 70 mg free acid tablet (Test 1); Drug: Tafamidis 61 mg free acid capsule (Reference)

Interventions

Tafamidis 61 mg free acid tablet (Test 1) DRUG

Tafamidis 61 mg free acid tablet (Test 1)

Reference capsule followed by Test 1 tablet followed by Test 2 tablet; Reference capsule followed by Test 2 tablet followed by Test 1 tablet; Test 1 tablet followed by Reference capsule followed by Test 2 tablet; Test 1 tablet followed by Test 2 tablet followed by Reference capsule; Test 2 tablet followed by Reference capsule followed by Test 1 tablet; Test 2 tablet followed by Test 1 tablet followed by Reference capsule

Tafamidis 70 mg free acid tablet (Test 1) DRUG

Tafamidis 61 mg free acid tablet (Test 1)

Reference capsule followed by Test 1 tablet followed by Test 2 tablet; Reference capsule followed by Test 2 tablet followed by Test 1 tablet; Test 1 tablet followed by Reference capsule followed by Test 2 tablet; Test 1 tablet followed by Test 2 tablet followed by Reference capsule; Test 2 tablet followed by Reference capsule followed by Test 1 tablet; Test 2 tablet followed by Test 1 tablet followed by Reference capsule

Tafamidis 61 mg free acid capsule (Reference) DRUG

Tafamidis 61 mg free acid capsule (Reference)

Reference capsule followed by Test 1 tablet followed by Test 2 tablet; Reference capsule followed by Test 2 tablet followed by Test 1 tablet; Test 1 tablet followed by Reference capsule followed by Test 2 tablet; Test 1 tablet followed by Test 2 tablet followed by Reference capsule; Test 2 tablet followed by Reference capsule followed by Test 1 tablet; Test 2 tablet followed by Test 1 tablet followed by Reference capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and Sex:
• Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.
• Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).

You may not qualify if:

• Medical Conditions:
• 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).
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, or HCVAb. Hepatitis B vaccination is allowed.
• Hypersensitivity to any component of the formulations.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Prior/Concomitant Therapy:
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
• Current use of any prohibited concomitant medication(s) or participant unwilling or unable to use a required concomitant medication(s).
• Prior/Concurrent Clinical Study Experience:
• Previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
• Diagnostic Assessments:
• A positive urine drug test. A single repeat for positive drug screen may be allowed.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \<60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
• Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF \>450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tafamidis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: February 27, 2024
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)