Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01655511 |
Recruitment Status
:
Completed
First Posted
: August 2, 2012
Last Update Posted
: September 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
TTR Cardiomyopathy | Drug: Tafamidis | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Basic Science |
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 |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Period 1
240 mg tafamidis arm
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Drug: Tafamidis
240 mg, solution, single dose
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Experimental: Period 2
480 mg arm
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Drug: Tafamidis
480 mg, solution, single dose
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Experimental: Period 3
TBD dose
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Drug: Tafamidis
TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
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- 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 ]
- Cmax - Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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)] [ Time Frame: 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 - ∞)] [ Time Frame: 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) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
- Transthyretin blood concentration in mg/dL [ Time Frame: Days 0,1,2,3,4,5,6 ]
- Transthyretin stabilization (%) [ Time Frame: Days 0,1,2,3,4,5,6 ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655511
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01655511 History of Changes |
Other Study ID Numbers: |
B3461040 |
First Posted: | August 2, 2012 Key Record Dates |
Last Update Posted: | September 27, 2012 |
Last Verified: | September 2012 |
Keywords provided by Pfizer:
Pharmacokinetic pharmacodynamic |
Additional relevant MeSH terms:
Cardiomyopathies Heart Diseases Cardiovascular Diseases |