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

NCT05498701 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B3461103
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Tafamidis, B3461103

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics(PK) Parameter - Area Under the Concentration-time Curve to Infinity (AUCinf) of PF-06291826

  AUCinf is defined as area under the concentration-time curve from time 0 to infinity, and calculated by AUC(0-tlast) + (Clast\*/kel), where Clast\* is the estimated plasma concentration at the last quantifiable time point (Clast) estimated form the log-linear regression analysis Clast\* = Clast x e\^(-kel x tlast)

  Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose

• PK Parameter - Maximum Observed Concentration (Cmax) of PF-06291826

  Cmax is defined as maximum observed concentration.

  Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose

Study Arms (2)

Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)

EXPERIMENTAL

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.

Drug: Tafamidis free acid tablet (Test); Drug: Tafamidis meglumine capsule (Reference)

Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed)

EXPERIMENTAL

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.

Drug: Tafamidis free acid tablet (Test); Drug: Tafamidis meglumine capsule (Reference)

Interventions

Tafamidis free acid tablet (Test) DRUG

12.2 mg tafamidis free acid tablet (Test)

Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed); Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)

Tafamidis meglumine capsule (Reference) DRUG

Commercial 20 mg tafamidis meglumine capsule (Reference)

Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed); Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)

Eligibility Criteria

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

You may qualify if:

• 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 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 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
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) 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, dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. (Refer to Section 6.9 Prior and Concomitant Therapy for additional details).
• Current use of any prohibited concomitant medication(s) or participant unwilling/unable to use a permitted concomitant medication(s). Refer to Section 6.9 Prior and Concomitant Therapy.
• Prior/Concurrent Clinical Study Experience:
• Previous administration with an investigational product (drug or vaccine) within 6 months (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.
• Screening seated BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of seated rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), 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 the uncorrected QT interval is \>450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. 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)

Pharma Medica Research Inc

Toronto, Ontario, M1S 3V6, Canada

Location

Related Links

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

MeSH Terms

Interventions

tafamidis

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 10, 2022
• First Posted: August 12, 2022
• Study Start: September 29, 2022
• Primary Completion: December 18, 2022
• Study Completion: December 19, 2022
• Last Updated: June 3, 2024
• Results First Posted: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)