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Trial registered on ANZCTR


Registration number
ACTRN12624001022550
Ethics application status
Approved
Date submitted
24/07/2024
Date registered
22/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 312508 0
MTS201-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 334373 0
Type 2 Diabetes Mellitus 334644 0
Condition category
Condition code
Metabolic and Endocrine 331013 331013 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves evaluation of MTS-201 in Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and in Combination with sitagliptin.

Part A (SAD): Participants will receive a single dose of MTS-201 or placebo oral capsules on Day 1 at up to 4 dose regimens:
• Cohort 1: 50 mg
• Cohort 2: 150 mg
• Cohort 3: 450 mg
• Cohort 4: 900 mg

The decision to escalate between dose levels in Part A will be based upon review of blinded available safety, tolerability and pharmacokinetic (PK) data, up to and including Day 4 from the current cohort, by a Safety Review Committee (SRC).

Part B (MAD): Participants will receive once daily dose of MTS-201 or placebo oral capsules for 14 days at up to 3 dose regimens (3 cohorts) in the range from 150mg up to 600mg (actual dosage to be determined based on data from Part A).

The decision to proceed from Part A to Part B will be based upon review of blinded available safety for Part A cohorts by an SRC.

Part C (Combination): Participants will receive once daily dose of 300mg MTS-201 + Sitagliptin 100mg or placebo oral capsules for 14 days.
The decision to proceed to Part C will be based upon review of blinded available safety of Part B cohorts by an SRC.

Study drug will be administered to the participants by the site staff while admitted at the clinical site. Adherence to the intervention will be done via supervised drug administration.
Intervention code [1] 329026 0
Treatment: Drugs
Comparator / control treatment
Placebo capsule containing microcrystalline cellulose
Control group
Placebo

Outcomes
Primary outcome [1] 338779 0
To evaluate the safety and tolerability of single dose of MTS-201 in healthy volunteers
Timepoint [1] 338779 0
AE's and vital signs assessed daily at Screening, Baseline (Day -1), Day 1, Day 2, Day 3, Day 4 and Follow up on Day 15.

Clinical laboratory parameters assessed at Screening, Baseline (Day -1), Day 2, Day 4 and Follow up on Day 15.

Sonogram assessed at Screening, Baseline (Day -1), Day 1, Day 2 and Day 4.

ECG completed daily at Screening, Baseline (Day -1), pre-dose Day 1 then 1 and 4 hrs post dose, Day 2, Day 3, Day 4 and Follow up on Day 15.
Primary outcome [2] 338861 0
To evaluate the safety and tolerability of multiple oral doses of MTS-201 in healthy volunteers
Timepoint [2] 338861 0
AE's will be assessed daily at Baseline (Day -1) through Day 17 and Follow up on Day 28 (EOS visit).

Vital signs will be measured at Screening, Baseline (Day -1), pre-dose Day 1 0.5, 1, 2, 4, 8 and 12 hours post-dose, Day 2 to Day 11, pre-dose Day 12 and Day 13 then 1 and 4 hours post-dose, pre-dose Day 14 0.5, 1, 2, 4, 8 and 12 hours post-dose, Day 15, Day 16 and Day 28 (EOS visit).

Clinical laboratory parameters assessed at Baseline (Day -1), pre-dose on Days 2, 4, 7, 9, 11, 14 then Day 16 post-dose and Day 28 (EOS visit).

Sonogram assessed at Screening, Baseline (Day -1), post-dose on Day 1, 4, 7, 11 and Day 15.

ECG completed at Screening, Baseline (Day -1), pre-dose and post-dose on Days 1, 4, 7, 9, 11 and Day 14 then on Day 28 (EOS visit).
Primary outcome [3] 338862 0
To evaluate the safety and tolerability of multiple oral doses of MTS-201 in combination with sitagliptin in healthy volunteers
Timepoint [3] 338862 0
AE's will be assessed daily at Baseline (Day -1) through Day 17 and Follow up on Day 28 (EOS visit).

Vital signs will be measured at Screening, Baseline (Day -1), pre-dose Day 1 0.5, 1, 2, 4, 8 and 12 hours post-dose, Day 2 to Day 11, pre-dose Day 12 and Day 13 then 1 and 4 hours post-dose, pre-dose Day 14 0.5, 1, 2, 4, 8 and 12 hours post-dose, Day 15, Day 16 and Day 28 (EOS visit).

Clinical laboratory parameters assessed at Baseline (Day -1), pre-dose on Days 2, 4, 7, 9, 11, 14 then Day 16 post-dose and Day 28 (EOS visit).

Sonogram assessed at Screening, Baseline (Day -1), post-dose on Day 1, 4, 7, 11 and Day 15.

ECG completed at Screening, Baseline (Day -1), pre-dose and post-dose on Days 1, 4, 7, 9, 11 and Day 14 then on Day 28 (EOS visit).
Secondary outcome [1] 437407 0
To evaluate the pharmacokinetics of single oral dose of MTS-201 in healthy volunteers
Timepoint [1] 437407 0
Blood samples will be collected pre-dose Day 1 - 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose, Day 2 24 and 36 hrs post-dose, Day 3 48 hrs post-dose and Day 4 72 hrs post-dose.

Urine samples will be collected pre-dose Day 1 then 6 and 12 hrs post-dose, Day 2 up to 24 hrs post-dose, Day 3 up to 48 hrs post-dose, Day 4 up to 72 hrs post-dose.
Secondary outcome [2] 437713 0
To evaluate the pharmacokinetics of multiple oral doses of MTS-201 in healthy volunteers
Timepoint [2] 437713 0
Blood samples will be collected pre-dose Day 1 - 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose, pre-dose on Days 2, 3, 4, 7, 9 and Day 11, pre-dose Day 14 - 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose, Day 15 24 and 36 hrs post-dose, Day 16 48 hrs post-dose, Day 17 72 hrs post-dose.

Urine samples will be collected pre-dose Day 1 then 6 and 12 hrs post-dose, Day 2 between 12 and 24 hrs post-dose, pre-dose Day 14 then 6 and 12 hrs post-dose, Day 15 between 12 and 24 hrs post-dose,
Secondary outcome [3] 437714 0
To evaluate the pharmacokinetics of multiple oral doses of MTS-201 in combination with sitagliptin in healthy volunteers
Timepoint [3] 437714 0
Blood samples will be collected pre-dose Day 1 - 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose, pre-dose on Days 2, 3, 4, 7, 9 and Day 11, pre-dose Day 14 - 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose, Day 15 24 and 36 hrs post-dose, Day 16 48 hrs post-dose, Day 17 72 hrs post-dose.

Urine samples will be collected pre-dose Day 1 then 6 and 12 hrs post-dose, Day 2 between 12 and 24 hrs post-dose, pre-dose Day 14 then 6 and 12 hrs post-dose, Day 15 between 12 and 24 hrs post-dose,

Eligibility
Key inclusion criteria
Healthy adult males and females, 18 to 65 years of age, inclusive and BMI between 18.0 and 32.0 kg/m2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 screening.
25. Donation of blood or plasma within 3 months prior to first dose of study drug, or loss of whole blood of more than 480 mL within 3 months prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug.
26. Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day -1.
27. Not recorded at least 1 bowel movement prior to study site check-in on Day -1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet the study eligibility criteria will be assigned a randomisation number prior to dosing on Day 1, which corresponds to a study treatment (MTS-201, MTS-201 in combination with sitagliptin or placebo ). Code-break tamper-evident envelopes containing treatment allocation per participant will be provided to the study site for emergency unblinding if required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of MTS-201 or placebo will be performed using a block randomization algorithm and will be documented in the study randomization schedule. The randomization schedule will be prepared by an unblinded statistician and maintained under controlled access.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/09/2024
Actual
23/09/2024
Date of last participant enrolment
Anticipated
28/10/2025
Actual
Date of last data collection
Anticipated
24/11/2025
Actual
Sample size
Target
72
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316932 0
Commercial sector/Industry
Name [1] 316932 0
METiS Pharmaceuticals Australia Pty Ltd
Country [1] 316932 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
METiS Pharmaceuticals Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319197 0
None
Name [1] 319197 0
Address [1] 319197 0
Country [1] 319197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315682 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 315682 0
Ethics committee country [1] 315682 0
Australia
Date submitted for ethics approval [1] 315682 0
10/07/2024
Approval date [1] 315682 0
08/08/2024
Ethics approval number [1] 315682 0
2024-07-834

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135494 0
Dr Thomas Polasek
Address 135494 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 135494 0
Australia
Phone 135494 0
+61 458 162 715
Fax 135494 0
Email 135494 0
thomas.polasek@cmax.com.au
Contact person for public queries
Name 135495 0
Thomas Polasek
Address 135495 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 135495 0
Australia
Phone 135495 0
+61 458 162 715
Fax 135495 0
Email 135495 0
thomas.polasek@cmax.com.au
Contact person for scientific queries
Name 135496 0
Thomas Polasek
Address 135496 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 135496 0
Australia
Phone 135496 0
+61 458 162 715
Fax 135496 0
Email 135496 0
thomas.polasek@cmax.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.