Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01185184

Enrollment

Registered

2010-08-19

Start date

2010-08-31

Completion date

2010-08-31

Last updated

2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Relative bioavailability, controlled release, Phase 1, CP-690, 550

Brief summary

This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

Interventions

DRUGCP-690,550

Single doses separated by a minimum of 72 hour washout between treatments

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Months to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550	36 hours

Secondary

Measure	Time frame
Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550	9 days
Safety: laboratory tests, adverse events reporting, ECG and vital signs	9 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026