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

A Phase 1 Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of S-892216 in Healthy Adult Participants

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: S-892216; Drug: Carbamazepine

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON Lenexa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 49

Collaborators and Investigators

• Sponsor: Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; Carbamazepine; S-892216
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Sodium Channel Blockers; Membrane Transport Modulators; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Carbamazepine
• Other Study ID Numbers: 2315T1612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No