Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
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
1 other identifier
interventional
9
1 country
1
Brief Summary
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
August 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 27, 2012
September 1, 2012
2 months
July 12, 2012
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
vital signs, ECGs, and clinical laboratory tests.
Day 0 and Day 6
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
Period 1
EXPERIMENTAL240 mg tafamidis arm
Period 2
EXPERIMENTAL480 mg arm
Period 3
EXPERIMENTALTBD dose
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, males or females, 21 to 55 years old.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2012
First Posted
August 2, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 27, 2012
Record last verified: 2012-09