COVID-19
Conditions
Keywords
S-892216, Carbamazepine, COVID-19
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.
Interventions
DRUGS-892216
S-892216 will be administered orally as a tablet.
DRUGCarbamazepine
Carbamazepine will be administered orally as a tablet.
Sponsors
Shionogi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1-sequence, drug-drug interaction study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through Day 49 |
Countries
United States
Outcome results
None listed