Trials Sponsors Conditions Drugs Pricing

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

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)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (1)

Pharma Medica Research Inc

Toronto, Ontario, M1S 3V6, Canada

MeSH Terms

Interventions

tafamidis

Results Point of Contact

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

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Publication Agreements

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

Enrollment

22 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

August 10, 2022

First Posted

August 12, 2022

Study Start

September 29, 2022

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, 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.
+9 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations