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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: S-892216; Drug: Carbamazepine

• Registration Number: NCT06751017
• Lead Sponsor: Shionogi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-17
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Primary Completion: 2025-02-24
• Study Completion: 2025-02-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-892216	S-892216	Participants will receive S-892216 and carbamazepine.
S-892216	Carbamazepine	Participants will receive S-892216 and carbamazepine.

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of S-892216	Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of S-892216	Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Plasma Concentration of Carbamazepine	Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
Tmax of Carbamazepine	Day 35 (2 hours predose, 30 minutes to 24 hours postdose)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 49

Trial Locations

Locations (1)

ICON Lenexa; 🇺🇸 Lenexa, Kansas, United States