Healthy
Conditions
Keywords
Tafamidis
Brief 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.
Detailed description
This study will be a Phase 1, open-label, randomized, two-treatment, two-period, crossover, single dose bioequivalence study to compare 61 mg tafamidis free acid tablet (Test) to 61 mg tafamidis free acid capsule (Reference) administered under fed conditions in healthy adult participants.
Interventions
DRUGTafamidis (Reference)
61 milligrams (mg) free acid capsule
DRUGTafamidis (Test)
61 mg free acid tablet
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 \<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. 8. Renal impairment as defined by eGFR \<60 mL/min/1.73 m², which may be confirmed by a single repeat test, if necessary. 9. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (including, but not limited to, QTcF \>450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST segment and/or T wave 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 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by an investigator experienced in reading ECGs before excluding a participant. 10. 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: • ALT, AST, Bilirubin ≥1.5× 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. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve (AUCinf) | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168. | Area under the plasma concentration time profile from time zero extrapolated to infinite time. |
| Maximum observed plasma concentration (Cmax) | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 | Peak or maximum observed concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number or percentage of patients with abnormal physical examination findings | Baseline up to Day 53 | Assessment of abnormal physical examination findings during study participation |
| Number or percentage of patients with change from baseline in Clinical Laboratory parameters | Baseline up to Day 25 | Change in clinical laboratory parameters |
| Number or percentage of patients with change from baseline in vital sign measurements | Baseline up to Day 25 | Change in vital sign measurements |
| Number of patients with change in electrocardiogram (ECG) parameters | Baseline up to Day 25 | Change in ECG parameters |
| Incidence of adverse events | Baseline up to Day 53 (35 days after last dose) | Assessment of adverse events during study participation and up to 35 days after last dose |
Countries
Belgium
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed