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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

  • 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. - Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment. - History of adverse hematologic reaction to any drug, or a history of bone marrow depression. - History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson Syndrome. - Prior carbamazepine use that was discontinued for tolerability or adverse events, including a clinically significant decrease in platelets, white blood cells, or hemoglobin. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
1-sequence, drug-drug interaction study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
S-892216 		Participants will receive S-892216 and carbamazepine.
  • Drug: S-892216
    S-892216 will be administered orally as a tablet.
  • Drug: Carbamazepine
    Carbamazepine will be administered orally as a tablet.
    Other names:
    • Tegretol

Recruiting Locations

ICON Lenexa
Lenexa, Kansas 66219

More Details

NCT ID
NCT06751017
Status
Recruiting
Sponsor
Shionogi

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line
1-800-849-9707
Shionogiclintrials-admin@shionogi.co.jp

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.