S-892216 + Carbamazepine for Coronavirus

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Shionogi

Must be taking: Carbamazepine

Disqualifiers: Asian ancestry, Cardiovascular, Respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how carbamazepine affects the body's processing of S-892216, an experimental treatment, in healthy adults. Researchers seek to understand the interaction between these two drugs when taken together. Individuals who are generally healthy and have no history of severe skin reactions or serious medical conditions might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this experimental treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that carbamazepine is usually well-tolerated. It has treated conditions like epilepsy and nerve pain for many years. However, some people might experience side effects such as dizziness or nausea. Long-term use may affect organs.

Less information exists for S-892216 because it is still under study. This study is in an early phase, so researchers are still learning about its safety in humans. Participants receive close monitoring to ensure they remain healthy while taking it.

Overall, researchers aim to ensure the combination of these treatments is safe and effective. If considering joining a trial, discussing any concerns with the study team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for epilepsy, which often includes medications like carbamazepine that work by stabilizing electrical activity in the brain, S-892216 offers a fresh approach. This experimental drug is being looked into for its potential to interact differently when combined with carbamazepine, which could enhance its effectiveness or reduce side effects. Researchers are particularly excited about S-892216 because it might offer a novel mechanism of action that targets the condition in a new way, presenting a possibility for improved treatment outcomes for patients.

What evidence suggests that this trial's treatments could be effective?

Research has shown that S-892216, administered alongside carbamazepine in this trial, has strong antiviral effects, particularly against the virus causing COVID-19. Studies suggest it remains effective even in small doses, offering promise for infection treatment. In animal studies, S-892216 reduced the virus in infected hamsters. This treatment blocks a key part of the virus, preventing it from multiplying. Overall, early findings indicate that S-892216 could be a powerful tool in combating viral infections. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can safely take the study drugs. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

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

I have had bad reactions to drugs affecting my blood or bone marrow.

History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson Syndrome

I do not have any Asian grandparents.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of carbamazepine and S-892216 to assess pharmacokinetics

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbamazepine
• S-892216

Trial Overview The trial is testing how a drug called S-892216 behaves in the body when taken with another drug, Carbamazepine. It's looking at whether Carbamazepine changes the levels of S-892216 in healthy people over multiple doses.

How Is the Trial Designed?

Group I: S-892216 Experimental Treatment 2 Interventions

Participants will receive S-892216 and carbamazepine.

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11778574/

P-1079. In Vitro and in Vivo Antiviral Activity of S-892216, a ... Due to the strong antiviral activity of S-892216, it is suggested to be effective at low doses in clinical settings. DDI and safety will be ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06928051

A Study of S-892216 in Participants With COVID-19 The primary objective of this study is to investigate the antiviral effect of S-892216 in participants with coronavirus disease 2019 (COVID-19) due to ...

3. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.5c00754

A Second-Generation of SARS-CoV-2 3CL Protease Inhibitor ... S-892216 achieved high antiviral activity against SARS-CoV-2 variants by introducing a reversible covalent warhead to a nonpeptidic lead ...

4. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.2184/7989147

P-2028. Therapeutic Effect of Delayed Treatment with a ... Oral treatment with S-892216 exhibited therapeutic effect in SARS-CoV-2 infected hamsters. Furthermore, S-892216 showed comparable efficacy at lower dosages ...

5. shionogi.com shionogi.com/global/en/news/2023/05/20230517.html

Shionogi Expands its COVID-19 Product Portfolio by ... In pre-clinical trials, S-892216 demonstrated strong antiviral effect as well as ensitrelvir. In the Phase 1 clinical trial, Shionogi will ...

6. fishersci.com fishersci.com/store/msds?partNumber=AC344360050&productDescription=CARBAMAZEPINE%2C+98%25+5GR&vendorId=VN00032119&countryCode=US&language=en

SAFETY DATA SHEET Precautionary Statements. Prevention. Wash face, hands and any exposed skin thoroughly after handling. Do not eat, drink or smoke when using ...

7. in.gov in.gov/fssa/thehub/files/Carbamazepime_tablet.pdf

Safety Data Sheet This Safety Data Sheet has been provided to inform workers of the safety, health and environmental information associated with this product.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06751017?cond=COVID-19

A Drug-drug Interaction Study of S-892216 Coadministered ... Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead ...

9. northamerica.covetrus.com northamerica.covetrus.com/Content/SDS/072993.pdf

SAFETY DATA SHEET H360 - May damage fertility or the unborn child. H351 - Suspected of causing cancer. H373 - May cause damage to organs through prolonged or repeated.

10. reaganudall.org reaganudall.org/clinical-trial/drug-drug-interaction-study-s-892216-coadministered-carbamazepime-healthy-adult

A Drug-drug Interaction Study of S-892216 Coadministered ... The primary objective of this study is to investigate the effect of multiple-doseadministration of carbamazepine on the pharmacokinetics of S-892216 in healthy ...