Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000104954
Ethics application status
Approved
Date submitted
16/11/2019
Date registered
5/02/2020
Date last updated
16/09/2021
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MET642 in healthy subjects.
Scientific title
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MET642 after single and multiple ascending oral dose administration in healthy subjects
Secondary ID [1] 299695 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic steatohepatitis (NASH) 315047 0
Condition category
Condition code
Oral and Gastrointestinal 313377 313377 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MET642 is a tablet that is administered orally.
In Part A, eligible participants will be assigned to 1 of 4 groups based on when they participate in the study. Within each group, participants are randomly assigned to receive a single dose of MET642 or placebo. Doses range from 15mg to 300mg and will be determined and adjusted based on emerging data.
In Part B, eligible participants will be assigned to 1 of 4 groups based on when they participate in the study. Within each group, participants are randomly assigned to receive daily doses of MET642 or placebo for 2 weeks. Doses for will range from 2.5mg to 10mg and will be determined and adjusted based on emerging data.
Intervention code [1] 315961 0
Treatment: Drugs
Comparator / control treatment
Placebo is a sugar pill that has no active ingredient. Placebo will be administered as a tablet(s) orally. Participants will receive either a single dose of placebo, or once daily dosing of placebo for 2 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 321859 0
Safety and Tolerability as measured by the number of adverse events and serious adverse events, changes in vitals signs, ECGs, and laboratory values, and physical exam findings
Timepoint [1] 321859 0
For Part A (single-dose), safety will be assessed daily from start of dosing through 10 days after dosing.

For Part B (multiple-dose), safety will be assessed daily from start of dosing through 24 days after dosing.
Secondary outcome [1] 376497 0
Pharmacokinetic (PK) profile of MET642, including but not limited to: Cmax, Tmax, AUCinf, and T1/2. PK will assayed from blood plasma samples.
Timepoint [1] 376497 0
For Part A (single-dose study), PK timepoints will include the following: - a single pre-dose sample - samples every 2 hours after dosing for the first 12 hours - one sample 1 day after dosing - one sample 2 days after dosing - one sample 10 days after dosing For Part B (multiple-dose study), PK timepoints will include the following: - a single pre-dose sample - samples every 2 hours for the first 12 hours after the first dose - a single sample daily from Days 2 through 13 - samples every 2 hours after dosing on Day 14 - a single daily sample from Day 15 through Day 17 - a single sample on Day 28
Secondary outcome [2] 376498 0
Pharmacodynamic (PD) profile (C4 and FGF19) of MET642. PD will be assayed from blood plasma samples.
Timepoint [2] 376498 0
For Part A (single-dose study), PD timepoints will include the following: - a single pre-dose sample - samples every 2 hours after dosing for the first 12 hours - one sample 1 day after dosing - one sample 2 days after dosing - one sample 10 days after dosing For Part B (multiple-dose study), PD timepoints will include the following: - a single pre-dose sample - samples every 2 hours for the first 12 hours after the first dose - a single sample daily from Days 2 through 13 - samples every 2 hours after dosing on Day 14 - a single daily sample from Day 15 through Day 17 - a single sample on Day 28

Eligibility
Key inclusion criteria
Healthy subjects without any co-morbidities or clinically significant disease.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers and subjects with a history of drug and/or alcohol abuse or current drug and alcohol abuse, and subjects with a history of clinically significant disease.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
2/03/2020
Actual
18/03/2020
Date of last participant enrolment
Anticipated
Actual
27/08/2020
Date of last data collection
Anticipated
Actual
19/09/2020
Sample size
Target
112
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 304170 0
Commercial sector/Industry
Name [1] 304170 0
Metacrine
Country [1] 304170 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Metacrine
Address
3985 Sorrento Valley Blvd., Suite C
San Diego, CA 92121
Country
United States of America
Secondary sponsor category [1] 304399 0
None
Name [1] 304399 0
Address [1] 304399 0
Country [1] 304399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304644 0
Bellberry Limited
Ethics committee address [1] 304644 0
123 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 304644 0
Australia
Date submitted for ethics approval [1] 304644 0
17/12/2019
Approval date [1] 304644 0
18/02/2020
Ethics approval number [1] 304644 0

Summary
Brief summary
MET642 is a tablet that is taken once daily. This study will look at the safety of single and multiple doses of MET642 when compared to placebo. This study will also determine the PK and PD of MET642 in healthy subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97702 0
Dr Nicholas Farinola
Address 97702 0
CMAX Clinical Research
Level 5/18a North Terrace
Adelaide, SA 5000
Country 97702 0
Australia
Phone 97702 0
+61 08 7074 0000
Fax 97702 0
Email 97702 0
[email protected]
Contact person for public queries
Name 97703 0
Hubert Chen
Address 97703 0
Metacrine
3985 Sorrento Valley Blvd, Suite C
San Diego, CA 92121
Country 97703 0
United States of America
Phone 97703 0
+1 858 353 7169
Fax 97703 0
Email 97703 0
[email protected]
Contact person for scientific queries
Name 97704 0
Hubert Chen
Address 97704 0
Metacrine
3985 Sorrento Valley Blvd, Suite C
San Diego, CA 92121
Country 97704 0
United States of America
Phone 97704 0
+1 858 353 7169
Fax 97704 0
Email 97704 0
[email protected]

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.