NCT01655511CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- 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,
Study Overview
Brief Summary
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Period 1
Experimental
240 mg tafamidis arm
Intervention: Tafamidis (Drug)
Period 2
Experimental
480 mg arm
Intervention: Tafamidis (Drug)
Period 3
Experimental
TBD dose
Intervention: Tafamidis (Drug)
Outcomes
Primary Outcomes
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,
Time Frame: Day 0 and Day 6
vital signs, ECGs, and clinical laboratory tests.
Time Frame: Day 0 and Day 6
Secondary Outcomes
- Cmax - Maximum Observed Plasma Concentration (Cmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- 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)
- 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)
- 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)
- AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)](0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- 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)
- Transthyretin blood concentration in mg/dL(Days 0,1,2,3,4,5,6)
- Transthyretin stabilization (%)(Days 0,1,2,3,4,5,6)
Investigators
Study Sites (1)
Loading locations...
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