A Study of S-740792 in Healthy Adult Study Participants

Shionogi

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: S-740792 Tablet; Drug: Placebo; Drug: S-740792 Suspension; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06724978

2318VA711

Details and patient eligibility

About

This is a 3-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose and food effect) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose and drug-drug interaction) will investigate the safety, tolerability, and PK of S-740792, in addition, the effect of multiple doses of S-740792 on the PK of midazolam. Part 3 will investigate the relative bioavailability of S-740792 tablet compared to S-740792 suspension and the food effect on the PK of the S-740792 tablet.

Enrollment: 99 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive).

Key Exclusion Criteria:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological 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.
• Participants who require medication or other treatment (for example, dietary restrictions or physical therapy).
• Participants who have participated in any other clinical study involving an investigational study intervention or any other type of medical research within 28 days or 5 half-lives of that drug (if known), whichever is longer before signing of the informed consent form for this study or who are currently participating in such a study.
• Positive test results of the following at screening or within 6 months prior to administration of study intervention:
• hepatitis B surface antigen
• hepatitis C virus antibody
• serological test for syphilis
• human immunodeficiency virus antigen/antibody
• drug screen
• alcohol screen
• Participants who have used tobacco or nicotine-containing products (including electronic-cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission or a positive cotinine test at screening or on admission.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups

Part 1 (Single Ascending Dose)

Experimental group

Description:

Participants will receive S-740792 or placebo.

Treatment:

Drug: S-740792 Suspension

Drug: Placebo

Part 2 (Multiple Ascending Dose)

Experimental group

Description:

Participants will receive S-740792 or placebo, in addition to midazolam.

Treatment:

Drug: Midazolam

Drug: S-740792 Suspension

Drug: Placebo

Part 3 (Bioavailability)

Experimental group

Description:

Participants will receive S-740792 as a suspension and as a tablet.

Treatment:

Drug: S-740792 Suspension

Drug: S-740792 Tablet