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NCT Number: NCT01731327

A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.

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Key information

Conditions

Healthy

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 male subjects and/or healthy female subjects who are of non-childbearing potential.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
  • Clinically significant infections within the past 3 months

Treatment and study plan

tofacitinib modified-release (MR) formulation

Drug

A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.

Primary outcomes

  1. AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized

    Time frame: 72 hours post dose

  2. Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized

    Time frame: 72 hours post dose

Secondary outcomes

  1. AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized

    Time frame: 72 hours post dose

  2. AUCinf: Area Under the Curve From Time Zero to Infinity

    Time frame: 72 hours post dose

  3. Cmax: Maximum Observed Plasma Concentration

    Time frame: 72 hours post dose

  4. AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration

    Time frame: 72 hours post dose

  5. Tmax: Amount of time drug takes to reach Cmax

    Time frame: 72 hours post dose

  6. t ½: Terminal elimination half-life

    Time frame: 72 hours post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 21, 2012
Registry last updated
Dec 24, 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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