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Completed

NCT Number: NCT06751017

A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Lenexa

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-892216

Drug

S-892216 will be administered orally as a tablet.

carbamazepine

Drug

Carbamazepine will be administered orally as a tablet.

Other names: Tegretol

Primary outcomes

  1. Plasma Concentration of S-892216

    Time frame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)

  2. Time to Maximum Plasma Concentration (Tmax) of S-892216

    Time frame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)

  3. Plasma Concentration of Carbamazepine

    Time frame: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)

  4. Tmax of Carbamazepine

    Time frame: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)

Secondary outcomes

  1. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through Day 49

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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