A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
Status and phase
Completed
Phase 1
Conditions
Healthy Volunteers
Rheumatoid Arthritis
Treatments
Drug: CE 224,535
Drug: CE-224,535
Details and patient eligibility
About
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.
Enrollment
11 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
11 participants in 8 patient groups
Part1; controlled release formulation 4; 250 mg
Experimental group
Description:
one 250 mg controlled release tablet, once in the morning, in fasted state
Treatment:
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Part1; controlled release formulation 4; 500 mg
Experimental group
Description:
2x250 mg, once in the morning, in fasted state
Treatment:
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Part 1; controlled release formula 4; 1000 mg
Experimental group
Description:
4x250 mg tabs, once in the morning, in fasted state
Treatment:
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Part 1; controlled release formulation 4; 500 mg FED
Experimental group
Description:
2x250 mg, once in the morning , in fed state
Treatment:
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Part 2; IR formulation 500mg
Experimental group
Description:
4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1
Treatment:
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Part 2; IR formulation, 500 mg FED
Experimental group
Description:
4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1.
Treatment:
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Drug: CE-224,535
Part 2; controlled release formulation 5;500 mg, FASTED
Experimental group
Description:
2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1.
Treatment:
Drug: CE 224,535
Drug: CE 224,535
Part 2; controlled release formulation 5;500 mg, FED
Experimental group
Description:
2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1
Treatment:
Drug: CE 224,535
Drug: CE 224,535
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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