A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.

An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838058

Enrollment

Registered

2009-02-06

Start date

2009-01-31

Completion date

2009-03-31

Last updated

2009-10-14

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

Conditions

Healthy Volunteers, Rheumatoid Arthritis

Keywords

pharmacology formulation normal healthy volunteers food effect

Brief summary

The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.

Interventions

DRUGCE-224,535

one 250mg tablet, once in the morning in fasted state

DRUGCE 224,535

2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* aged 18-55 and healthy

Exclusion criteria

* severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse * pregnant or wanting to become pregnant

Design outcomes

Primary

Measure	Time frame
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2	48 hrs

Secondary

Measure	Time frame
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing	48 hrs

Countries

United States

Outcome results

None listed

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