Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01655511
First received: July 12, 2012
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
| Condition | Intervention | Phase |
|---|---|---|
|
TTR Cardiomyopathy |
Drug: Tafamidis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- vital signs, ECGs, and clinical laboratory tests. [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Transthyretin blood concentration in mg/dL [ Time Frame: Days 0,1,2,3,4,5,6 ] [ Designated as safety issue: No ]
- Transthyretin stabilization (%) [ Time Frame: Days 0,1,2,3,4,5,6 ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | July 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Period 1
240 mg tafamidis arm
|
Drug: Tafamidis
240 mg, solution, single dose
|
|
Experimental: Period 2
480 mg arm
|
Drug: Tafamidis
480 mg, solution, single dose
|
|
Experimental: Period 3
TBD dose
|
Drug: Tafamidis
TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655511
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655511
Locations
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 188770 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01655511 History of Changes |
| Other Study ID Numbers: | B3461040 |
| Study First Received: | July 12, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Pharmacokinetic pharmacodynamic |
Additional relevant MeSH terms:
|
Cardiomyopathies Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 23, 2016