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.
Not Provided
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
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.
ICON Lenexa
Lenexa, Kansas, United States
Not Provided