Clinical trial NCT06724978: A Study of S-740792 in Healthy Adult Study Participants
Official title: A Phase 1 Single- and Multiple-ascending-dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-740792 in Healthy Adult Study Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: First-in-human
S-740792
Midazolam
Bioavailability
Food Effect
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 3 will be a 3-sequence, 3-period crossover study.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 28
measure: Part 3: Plasma Concentration of S-740792
timeFrame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
measure: Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792
timeFrame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Secondary outcomes:
measure: Parts 1 and 2: Plasma Concentration of S-740792
timeFrame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
measure: Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792
timeFrame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
measure: Part 1: Plasma Concentration of S-740792 After a High-fat Meal
timeFrame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
measure: Part 1: Tmax of S-740792 After a High-fat Meal
timeFrame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
measure: Part 2: Plasma Concentration of Midazolam After Administration of S-740792
timeFrame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
measure: Part 2: Tmax of Midazolam After Administration of S-740792
timeFrame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
measure: Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 62
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit, Inc.
state: Florida
Study officials:
References: