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A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants
Lenexa, KS
Phase 1
Recruiting
Research Sponsored by Shionogi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
This study will not enroll participants with Asian ancestry, defined as individuals who have 1 or more Asian grandparent, due to significant increase of risk for carbamazepine-related serious dermatologic reactions almost exclusively in these populations
History of adverse hematologic reaction to any drug, or a history of bone marrow depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how taking multiple doses of carbamazepine affects how the body processes S-892216 in healthy adults.
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Who is the study for?
This trial is for healthy adults who can safely take the study drugs. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.Check my eligibility
What is being tested?
The trial is testing how a drug called S-892216 behaves in the body when taken with another drug, Carbamazepine. It's looking at whether Carbamazepine changes the levels of S-892216 in healthy people over multiple doses.See study design
What are the potential side effects?
Potential side effects aren't listed, but common ones for new drugs might include nausea, headaches, dizziness or allergic reactions. For Carbamazepine, possible side effects include drowsiness, balance/coordination issues and skin rashes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any Asian grandparents.
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I have had bad reactions to drugs affecting my blood or bone marrow.
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Select...
I stopped taking carbamazepine due to side effects or blood issues.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: S-892216Experimental Treatment2 Interventions
Participants will receive S-892216 and carbamazepine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbamazepine
2016
Completed Phase 4
~2690
Find a Location
Closest Location:ICON Lenexa· Lenexa, KS· 630 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ShionogiLead Sponsor
121 Previous Clinical Trials
42,065 Total Patients Enrolled