TTR Cardiomyopathy Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Crossover, Ascending Dose-Tolerance Study To Assess The Safety And Pharmacokinetics Of Tafamidis Doses Greater Than 120 Mg As Oral Solution In Healthy Volunteers
Verified date | September 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
Status | Completed |
Enrollment | 9 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy, males or females, 21 to 55 years old. - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Singapore | Pfizer Investigational Site | Singapore |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination, | Day 0 and Day 6 | Yes | |
Primary | vital signs, ECGs, and clinical laboratory tests. | Day 0 and Day 6 | Yes | |
Secondary | Cmax - Maximum Observed Plasma Concentration (Cmax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs | No | |
Secondary | tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs | No | |
Secondary | AUC0-24 - AreArea under the Concentration-Time Curve (AUC) | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs | No | |
Secondary | AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs | No | |
Secondary | AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs | No | |
Secondary | t½ - Plasma Decay Half-Life (t1/2) | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs | No | |
Secondary | Transthyretin blood concentration in mg/dL | Days 0,1,2,3,4,5,6 | No | |
Secondary | Transthyretin stabilization (%) | Days 0,1,2,3,4,5,6 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01775761 -
A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
|
Phase 1 |