| Trial ID: | L0437 |
| Source ID: | ACTRN12620000104954
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| Associated Drug: |
MET642
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| 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
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic steatohepatitis (NASH); <br>Non-alcoholic steatohepatitis (NASH);Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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| Interventions: |
MET642 is a tablet that is administered orally.<br>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
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| Outcome Measures: |
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 [For Part A (single-dose), safety will be assessed daily from start of dosing through 10 days after dosing.<br><br>For Part B (multiple-dose), safety will be assessed daily from start of dosing through 24 days after dosing. ]Pharmacokinetic (PK) profile of MET642, including but not limited to: Cmax, Tmax, AUCinf, and T1/2. PK will assayed from blood plasma samples. [ 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];Pharmacodynamic (PD) profile (C4 and FGF19) of MET642. PD will be assayed from blood plasma samples.[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]
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| Sponsor/Collaborators: |
Metacrine
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| Gender: |
All
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| Age: |
18 Years50 Years
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| Phases: |
Phase 1
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| Enrollment: |
112
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| Study Type: |
Interventional
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| Study Designs: |
Purpose: Treatment; Allocation: Randomised controlled trial;
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| Start Date: |
05/02/2020
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| Completion Date: |
19/09/2020
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| Results First Posted: |
16/09/2021
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| Last Update Posted: |
20 September 2021
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| Locations: |
Australia
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| URL: |
https://anzctr.org.au/ACTRN12620000104954.aspx
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