A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Shionogi
No Placebo Group
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to investigate the effect of multiple-dose administration of carbamazepine on the pharmacokinetics of S-892216 in healthy adults.
Eligibility Criteria
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.Inclusion Criteria
Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram, at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety
Body mass index ≥18.5 and ≤32.0 kilograms/meter squared
Exclusion Criteria
I have had bad reactions to drugs affecting my blood or bone marrow.
History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson Syndrome
I do not have any Asian grandparents.
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Treatment Details
Interventions
- Carbamazepine (Other)
- S-892216 (Other)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: S-892216Experimental Treatment2 Interventions
Participants will receive S-892216 and carbamazepine.
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Who Is Running the Clinical Trial?
Shionogi
Lead Sponsor
Trials
122
Recruited
42,100+
Dr. Isao Teshirogi
Shionogi
Chief Executive Officer since 2008
PhD in Pharmaceutical Sciences from the University of Tokyo
Dr. Takuko Sawada
Shionogi
Chief Medical Officer since 2022
MD from a recognized institution (specific details not found)