Clinical trial NCT06751017: A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants
Official title: A Phase 1 Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of S-892216 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: S-892216
Carbamazepine
COVID-19
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1-sequence, drug-drug interaction study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Plasma Concentration of S-892216
timeFrame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of S-892216
timeFrame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
measure: Plasma Concentration of Carbamazepine
timeFrame: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
measure: Tmax of Carbamazepine
timeFrame: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 49
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
Study officials:
References: