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NCT Number: NCT01499004

A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.

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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 females 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 (CP-690,550) modified-release formulation A

Drug

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.

tofacitinib (CP-690,550) modified-release formulation B1

Drug

A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food

tofacitinib (CP-690,550) modified-release formulation B2

Drug

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food

tofacitinib (CP-690,550) immediate-release formulation

Drug

A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food

Primary outcomes

  1. AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time

    Time frame: 72 hours post dose

  2. AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration

    Time frame: 72 hours post dose

  3. Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)

    Time frame: 72 hours post dose

  4. Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration

    Time frame: 72 hours post dose

  5. t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma

    Time frame: 72 hours post dose

Secondary outcomes

  1. Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation

    Time frame: 24 hours post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 26, 2011
Registry last updated
Jan 12, 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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