A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants

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

  • COVID-19

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