A study to learn how different forms of study medicine tafamidis are taken up into the blood in healthy adults

Phase 1

• Conditions: aransthyretin amyloid cardiomyopathy; MedDRA version: 26.1Level: PTClassification code: 10089650Term: Hereditary ATTR amyloid cardiomyopathy Class: 100000004850; MedDRA version: 26.1Level: LLTClassification code: 10089617Term: Wild type ATTR amyloid cardiomyopathy Class: 100000004848; MedDRA version: 20.0Level: PTClassification code: 10002022Term: Amyloidosis Class: 100000004870; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-509241-12-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Study Completion: 2024-05-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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., Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (99 lb).

Exclusion Criteria

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 human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed. - Hypersensitivity to any component of the formulations., 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: - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), Bilirubin =1.5 × upper limit of normal (ULN). Participants with a history of Gilbert’s syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is =ULN., History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine)., 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., 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)., 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)., A positive urine drug test. A single repeat for positive drug screen may be allowed., Screening supine blood pressure (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 electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTc corrected using Fridericia’s formula (QTcF) >450 ms, complete left bundle branch block (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 QTc

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified