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

NCT ID: NCT06751017

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2025-02-24

Brief Summary

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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-892216

Participants will receive S-892216 and carbamazepine.

Group Type: EXPERIMENTAL

S-892216

Intervention Type: DRUG

S-892216 will be administered orally as a tablet.

Carbamazepine

Intervention Type: DRUG

Carbamazepine will be administered orally as a tablet.

Interventions

S-892216

S-892216 will be administered orally as a tablet.

Intervention Type: DRUG

Carbamazepine

Carbamazepine will be administered orally as a tablet.

Intervention Type: DRUG

Other Intervention Names

Tegretol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Lenexa

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

2315T1612

Identifier Type: -

Identifier Source: org_study_id