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

Obesity Clinical Trial

Official title:

A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247970
• Other study ID #: 2018N1111
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2023
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 1, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• S-309309
Capsule administered orally
• Midazolam
Syrup administered orally
• Placebo
Matching capsule to S-309309 administered orally

Locations

Country	Name	City	State
United States	ICON Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Up to Day 28
Secondary	Part 1: Maximum Plasma Concentration (Cmax) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	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
Secondary	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
Secondary	Part 1: Terminal Elimination Rate Constant (?z) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Mean Residence Time (MRT) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Apparent Total Clearance (CL/F) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Apparent Volume of Distribution (Vz/F) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Renal Clearance (CLR) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Fraction of Dose Excreted in Urine (Feu) of S-309309		0 (predose) up to 144 hours postdose on Day 1 to Day 21
Secondary	Part 1: Change From Baseline of Electrocardiogram (ECG) Parameters: QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), Pulse Rate (PR) Interval, and Combination of the Q, R, and S Waves (QRS) Duration		Baseline, Day 2, 5, 7 and 16
Secondary	Part 1: Change From Baseline of ECG Parameter: Heart Rate (HR)		Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Secondary	Part 1: Placebo-Corrected Change From Baseline of ECG Parameters: QTcF, PR Interval, and QRS Duration		Baseline, Day 2, 5, 7 and 16
Secondary	Part 1: Placebo-Corrected Change From Baseline of ECG Parameter: HR		Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Secondary	Part 1: Number of Participants With Categorical Outlier Values for HR, QTcF, PR, and QRS		Baseline up to Day 16
Secondary	Part 1: Number of Participants With Treatment-Emergent Changes for T-wave Morphology and Presence of U-wave		Baseline up to Day 16
Secondary	Part 2: Cmax of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: Tmax of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: AUC of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: t1/2,z of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: ?z of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: CL/F of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: Vz/F of S-309309 and Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: MRT of Midazolam		0 (predose) up to 24 hours postdose on Day -2 to Day 16
Secondary	Part 2: Number of Participants with TEAEs After Coadministration with Midazolam		Up to Day 28