Back to resultsSafety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
Primary Purpose
TTR Cardiomyopathy
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Tafamidis
Tafamidis
Tafamidis
Sponsored by
About this trial
This is an interventional basic science trial for TTR Cardiomyopathy focused on measuring Pharmacokinetic, pharmacodynamic
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Period 1
Period 2
Period 3
Arm Description
240 mg tafamidis arm
480 mg arm
TBD dose
Outcomes
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,
vital signs, ECGs, and clinical laboratory tests.
Secondary Outcome Measures
Cmax - Maximum Observed Plasma Concentration (Cmax)
tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax)
AUC0-24 - AreArea under the Concentration-Time Curve (AUC)
AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
t½ - Plasma Decay Half-Life (t1/2)
Transthyretin blood concentration in mg/dL
Transthyretin stabilization (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01655511
Brief Title
Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TTR Cardiomyopathy
Keywords
Pharmacokinetic, pharmacodynamic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Period 1
Arm Type
Experimental
Arm Description
240 mg tafamidis arm
Arm Title
Period 2
Arm Type
Experimental
Arm Description
480 mg arm
Arm Title
Period 3
Arm Type
Experimental
Arm Description
TBD dose
Intervention Type
Drug
Intervention Name(s)
Tafamidis
Intervention Description
240 mg, solution, single dose
Intervention Type
Drug
Intervention Name(s)
Tafamidis
Intervention Description
480 mg, solution, single dose
Intervention Type
Drug
Intervention Name(s)
Tafamidis
Intervention Description
TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
Primary Outcome Measure Information:
Title
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
Title
vital signs, ECGs, and clinical laboratory tests.
Time Frame
Day 0 and Day 6
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Transthyretin blood concentration in mg/dL
Time Frame
Days 0,1,2,3,4,5,6
Title
Transthyretin stabilization (%)
Time Frame
Days 0,1,2,3,4,5,6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461040&StudyName=Safety%20And%20Pharmacokinetic%20Assessment%20Of%20Orally%20Administered%20Tafamidis%20In%20Healthy%20Volunteers
Description
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Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
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