ClinicalTrials.Veeva

Menu

A Study to Assess S-309309 in Healthy and Obese Participants

Shionogi logo

Shionogi

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Drug: Midazolam
Drug: Placebo
Drug: S-309309

Study type

Interventional

Funder types

Industry

Identifiers

NCT05247970
2018N1111

Details and patient eligibility

About

The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.

Full description

This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group.

Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.

Enrollment

74 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG at the Screening Visit and upon admission to the clinical research unit (CRU).
  • Body weight ≥50 kilograms (kg), and body mass index (BMI) within the range ≥18.5 to <30.0 kilogram/meter square (kg/m^2) for all groups except Group G-2. For Group G-2, BMI ≥ 30 to < 40 kg/m2 at the Screening Visit.

Exclusion criteria

  • History or presence of/significant history of or current 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.
  • Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  • Breast cancer within the past 10 years.
  • Unable to swallow capsules.
  • Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 3 patient groups, including a placebo group

Part 1: S-309309
Experimental group
Description:
Participants will receive S-309309 at specific timepoints in a fasted state.
Treatment:
Drug: S-309309
Part 2: S-309309 and Midazolam
Experimental group
Description:
Participants will receive S-309309 and Midazolam at specific timepoints fed state.
Treatment:
Drug: Midazolam
Drug: S-309309
Part 1 and 2: Placebo
Placebo Comparator group
Description:
Participants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state.
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems