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

NCT05247970 | Completed Phase 1 FDA Drug

• 1 other identifier: 2018N1111
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Up to Day 28

Secondary Outcomes (25)

• Part 1: Maximum Plasma Concentration (Cmax) of S-309309

  0 (predose) up to 144 hours postdose on Day 1 to Day 21

• Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309

  0 (predose) up to 144 hours postdose on Day 1 to Day 21

• Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309

  0 (predose) up to 144 hours postdose on Day 1 to Day 21

• Part 1: Terminal Elimination Half-Life (t1/2,z) of S-309309

  0 (predose) up to 144 hours postdose on Day 1 to Day 21

• Part 1: Terminal Elimination Rate Constant (λz) of S-309309

  0 (predose) up to 144 hours postdose on Day 1 to Day 21

Study Arms (3)

Part 1: S-309309

EXPERIMENTAL

Participants will receive S-309309 at specific timepoints in a fasted state.

Drug: S-309309

Part 2: S-309309 and Midazolam

EXPERIMENTAL

Participants will receive S-309309 and Midazolam at specific timepoints fed state.

Drug: S-309309; Drug: Midazolam

Part 1 and 2: Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state.

Drug: Placebo

Interventions

S-309309 DRUG

Capsule administered orally

Part 1: S-309309; Part 2: S-309309 and Midazolam

Midazolam DRUG

Syrup administered orally

Part 2: S-309309 and Midazolam

Placebo DRUG

Matching capsule to S-309309 administered orally

Part 1 and 2: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• Ishibashi T, Tanioka H, Ikehara T, Kezbor S, Sonoyama T. Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity. Clin Drug Investig. 2025 Feb;45(2):85-99. doi: 10.1007/s40261-024-01418-3. Epub 2025 Jan 20.

  PMID: 39832041 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 21, 2022
• Study Start: January 4, 2022
• Primary Completion: October 20, 2022
• Study Completion: November 1, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

US (1)