A Randomised, Double-blind, Placebo-controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MTS-201 and MTS-201 in Combination with Sitagliptin in Healthy Volunteers

Phase 1

• Conditions: Obesity; Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12624001022550
• Lead Sponsor: METiS Pharmaceuticals Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-22
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Healthy adult males and females, 18 to 65 years of age, inclusive and BMI between 18.0 and 32.0 kg/m2.

Exclusion Criteria

1.Known hypersensitivity to the study drug or any of the study drug ingredients.
2.History of anaphylaxis or other significant allergy.
3.History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder including any acute illness, within the past 3 months determined by the investigator to be clinically relevant or could negatively impact the ability to comply with all procedures.
4.History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
5.Any surgery on the stomach (such as gastric bypass) or small intestine or colon, excluding appendectomy
6.Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
7.Presence of clinically relevant immunosuppression.
8.Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal tract.
9.History of cholecystectomy, gallstones or gallbladder disorders.
10.History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
11.Presence or having sequelae of gastrointestinal tract, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
12.Elevated Liver function test results
13.Renal impairment
14.A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
15.Positive drugs of abuse test or alcohol breath test results at the screening visit and/or on admission to the study site on Day 1.
16.History of alcohol abuse, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment.
17.Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer. Participants will be required to abstain from the consumption of alcohol for at least 24 hours prior to check-in (Day -1), and while confined to the study site.
18.Volunteer smokes more than 5 cigarettes or equivalent nicotine-containing products per week, and/or the volunteer is unwilling to abstain from smoking or the use of nicotine-containing products for 72 hours prior to check-in on Day -1 and throughout the confinement period at the study site.
19.Females who are breastfeeding or planning to breastfeed.
20.Unable to swallow oral medication.
21.Use of any prescription or over-the-counter (OTC) medication (including herbal products, diet aids, vitamins, and hormone supplements) within 10 days prior to the first dose of study drug, except use of contraceptives, the use of paracetamol (up to 2 g per day) for no more than 3 consecutive days and the use of ibuprofen (up to 1.2 g per day) for no more than 3 consecutive days.
22.Prior use of GLP-1 or GLP-2 agonist drugs or DPP-4 inhibitor drugs (gliptins).
23.Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to first dose of study drug.
24.Use of any vaccinations within 30 days prior to scre

Study & Design

• Study Type: Interventional
• Study Design: Not specified