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

NCT06751017 | Completed Phase 1 FDA Drug

• 1 other identifier: 2315T1612
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

S-892216; Carbamazepine; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of Participants Experiencing Treatment-emergent Adverse Events

  Day 1 through Day 49

Study Arms (1)

S-892216

EXPERIMENTAL

Participants will receive S-892216 and carbamazepine.

Drug: S-892216; Drug: Carbamazepine

Interventions

S-892216 DRUG

S-892216 will be administered orally as a tablet.

S-892216

Carbamazepine DRUG

Carbamazepine will be administered orally as a tablet.

Also known as: Tegretol

S-892216

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

ICON Lenexa

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1-sequence, drug-drug interaction study

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 17, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)