← Back to all trials
Terminated
NCT07470866
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions
Conditions: Healthy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 24
Sponsor: Pfizer
Location: Pfizer Clinical Research Unit - Brussels Brussels Bruxelles-capitale, Région de
Summary
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.
Eligibility Criteria
Inclusion Criteria
Age and Sex:
1. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Other Inclusion Criteria:
2. BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria
Medical Conditions:
1. 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.
2. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years 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.
Prior/Concomitant Therapy:
3. 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.
4. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
Prior/Concurrent Clinical Study Experience:
5. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Diagnostic Assessments:
6. A positive urine drug test. A single repeat for positive drug screen may be allowed.
7. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \
Source: ClinicalTrials.gov (NCT07470866). StuddyBuddy aggregates publicly available trial information.