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

The primary objective of this study is to investigate the effect of multiple-doseadministration of carbamazepine on the pharmacokinetics of S-892216 in healthy adults.

Detailed Description

Not Provided

Completed
COVID-19

Drug: S-892216

S-892216 will be administered orally as a tablet.

Drug: Carbamazepine

Carbamazepine will be administered orally as a tablet.
Other Name: Tegretol

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
United States
Locations

ICON Lenexa
Lenexa, Kansas, United States

Not Provided

NCT Number
Keywords
S-892216
Carbamazepine
Covid-19
MeSH Terms
COVID-19
Carbamazepine