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

Completed · Phase 1

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT06751017

Run by

Shionogi

People needed

16

Starts

2024-12-17

Expected to finish

2025-02-24

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• Note: Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• ICON Lenexa — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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