A study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MET642 in healthy subjects.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000104954

Enrollment

Registered

2020-02-05

Start date

2020-03-18

Completion date

2020-08-27

Last updated

2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy subjects without any co-morbidities or clinically significant disease.

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.

Outcome results