Actively Recruiting
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions
Led by Pfizer · Updated on 2026-04-24
24
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking two different forms of tafamidis by mouth under fed conditions.
CONDITIONS
Official Title
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older (or minimum age of consent per local regulations) who are overtly healthy based on medical evaluation including history, physical exam, labs, and cardiac monitoring
- Body Mass Index (BMI) between 16 and 32 kg/m2
- Total body weight greater than 45 kg (99 pounds)
- Provided signed informed consent indicating understanding of study details
You will not qualify if you...
- History or evidence of significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (except untreated, asymptomatic seasonal allergies)
- Conditions affecting drug absorption such as gastrectomy or cholecystectomy
- History or positive test for HIV, hepatitis B or C (vaccination allowed)
- Hypersensitivity to any study drug components
- Any medical or psychiatric condition increasing risk or making participation unsuitable, including recent suicidal ideation or behavior
- Use of any prescription, nonprescription, dietary, or herbal drugs within 7 days or 5 half-lives before dosing
- Use of prohibited medications or unwillingness to use required concomitant medications
- Participation in other investigational drug or vaccine studies within 30 days or 5 half-lives before dosing
- Positive urine drug test (one repeat allowed)
- Elevated blood pressure above specified thresholds based on age
- Renal impairment with eGFR below 60 mL/min/1.73 m2
- ECG abnormalities affecting safety or study results, including prolonged QTcF or QRS intervals
- Clinical lab abnormalities such as ALT, AST, or bilirubin above 1.5 times the upper limit of normal (with exceptions for Gilbert's syndrome)
- History of alcohol abuse, binge drinking, or illicit drug use within 6 months
- Inability or unwillingness to comply with lifestyle requirements
- Investigator site staff and their family members involved in the study
- Use of tobacco or nicotine products exceeding 5 cigarettes per day or 2 tobacco chews per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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