COMPLETED

A Study of S-740792 in Healthy Adult Study Participants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-21
Study Completion:2025-09-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06724978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive).
  1. * 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.
  2. * Participants who require medication or other treatment (for example, dietary restrictions or physical therapy).
  3. * 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.
  4. * Positive test results of the following at screening or within 6 months prior to administration of study intervention:
  5. * hepatitis B surface antigen
  6. * hepatitis C virus antibody
  7. * serological test for syphilis
  8. * human immunodeficiency virus antigen/antibody
  9. * drug screen
  10. * alcohol screen
  11. * 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.

Contacts and Locations

Study Locations (Sites)

Fortrea Clinical Research Unit, Inc.
Daytona Beach, Florida, 32117
United States

Collaborators and Investigators

Sponsor: Shionogi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21
Study Completion Date2025-09-24

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2025-09-24

Terms related to this study

Keywords Provided by Researchers

  • First-in-human
  • S-740792
  • Midazolam
  • Bioavailability
  • Food Effect

Additional Relevant MeSH Terms

  • Healthy Participants