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Completed

NCT Number: NCT01655511

Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis

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Key information

Conditions

TTR Cardiomyopathy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tafamidis

Drug

240 mg, solution, single dose

Primary outcomes

  1. 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

  2. vital signs, ECGs, and clinical laboratory tests.

    Time frame: Day 0 and Day 6

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Transthyretin blood concentration in mg/dL

    Time frame: Days 0,1,2,3,4,5,6

  8. Transthyretin stabilization (%)

    Time frame: Days 0,1,2,3,4,5,6

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2012
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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