COVID-19Phase 1NCT06751017
A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants
A Phase 1 study testing S-892216 and Carbamazepine in people with COVID-19, run by Shionogi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- S-892216 and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to 24 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of S-892216 in Healthy Adult Participants
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.
- Conditions
- COVID-19
- Being tested
- S-892216, Carbamazepine
- Keywords
- S-892216, Carbamazepine, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-892216Drug
S-892216 will be administered orally as a tablet.
CarbamazepineDrug
Also called Tegretol
Carbamazepine will be administered orally as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| S-892216 | Experimental | Participants will receive S-892216 and carbamazepine. Receives: Drug: S-892216; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of S-892216
Measured: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of S-892216
Measured: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Plasma Concentration of Carbamazepine
Measured: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
Tmax of Carbamazepine
Measured: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
Secondary outcomes (1)
Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start17 Dec 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1-sequence, drug-drug interaction study
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751017
- Sponsor's protocol ID
- 2315T1612
- Status last verified
- Mar 2025
- First submitted
- 20 Dec 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of S-892216 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06751017
- Acronym / sponsor ID
- 2315T1612
- Conditions
- COVID-19
- Keywords
- S-892216, Carbamazepine, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1-sequence, drug-drug interaction study
| Arm | Type | Receives |
|---|---|---|
| S-892216 | Experimental | Drug: S-892216, Drug: CarbamazepineParticipants will receive S-892216 and carbamazepine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-892216S-892216 will be administered orally as a tablet. | Drug | S-892216 |
| CarbamazepineAlso: TegretolCarbamazepine will be administered orally as a tablet. | Drug | S-892216 |
Primary outcome
Plasma Concentration of S-892216
Time frame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of S-892216
Time frame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Plasma Concentration of Carbamazepine
Time frame: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
Tmax of Carbamazepine
Time frame: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
1 secondary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-892216 and Carbamazepine in people with COVID-19, run by Shionogi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of S-892216 (time frame: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.