Trials Sponsors Conditions Drugs Pricing

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
+5 more secondary outcomes

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 tabletDrug: 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 tabletDrug: Tafamidis meglumine capsule

Interventions

Tafamidis free acid tabletDrug

12.2 mg tafamidis free acid tablet

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

Tafamidis meglumine capsuleDrug

20 mg tafamidis meglumine soft gelatin capsule

Tafamidis Free acid tablet then tafamidis meglumine capsule

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

MeSH Terms

Interventions

tafamidis

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Enrollment

23 participants (actual enrollment reported by the registry).

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

Actual (reported)

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);
+7 more criteria

A Study to Determine the Bioequivalence of Two Doses of Tafamidis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (2)

Tafamidis Free acid tablet then tafamidis meglumine capsule

Tafamidis meglumine capsule then Tafamidis Free acid tablet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (2)

Tafamidis Free acid tablet then tafamidis meglumine capsule

Tafamidis meglumine capsule then Tafamidis Free acid tablet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations