A Study to Determine the Bioequivalence of Two Doses of Tafamidis

NCT04575116 | Completed Phase 1 FDA Drug

• 2 other identifiers: B3461095Tafamidis
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Study to characterize the bioequivalence of a 12.2 mg free acid tablets compared to commercial supply (tafamidis meglumine soft gelatin 20 mg capsule) in healthy participants under fasted conditions.

Conditions

Healthy

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

Secondary Outcomes (10)

• Area under the plasma concentration-time curve (AUC72)

  Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72

• Area under the plasma concentration-time curve (AUClast)

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

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

• Mean residence time (MRT)

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

• Plasma Decay Half-Life (t1/2)

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

Study Arms (2)

Tafamidis Free acid tablet then tafamidis meglumine capsule

EXPERIMENTAL

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

Drug: Tafamidis free acid tablet; Drug: Tafamidis meglumine capsule

Tafamidis meglumine capsule then Tafamidis Free acid tablet

EXPERIMENTAL

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

Drug: Tafamidis free acid tablet; Drug: Tafamidis meglumine capsule

Interventions

Tafamidis free acid tablet DRUG

12.2 mg tafamidis free acid tablet

Tafamidis Free acid tablet then tafamidis meglumine capsule; Tafamidis meglumine capsule then Tafamidis Free acid tablet

Tafamidis meglumine capsule DRUG

20 mg tafamidis meglumine soft gelatin capsule

Tafamidis Free acid tablet then tafamidis meglumine capsule; Tafamidis meglumine capsule then Tafamidis Free acid tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
• Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Capable of giving signed informed consent and compliance with study requirements and restrictions

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).
• History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, or HCVAb. Hepatitis B vaccination is allowed.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality 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.
• Prior/Concurrent Clinical Study Experience:
• Previous administration with an investigational drug 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.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine 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.
• Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval \>450 msec, 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 baseline uncorrected QT interval is \>450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
• Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
• AST or ALT level greater than or equal to 1.5 × upper limit of normal (ULN);

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

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: September 23, 2020
• First Posted: October 5, 2020
• Study Start: September 17, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)