A randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic, and pharmacodynamic study of MET409 after single and multiple ascending oral dose administration in healthy male subjects

A randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic, and pharmacodynamic study of MET409 after single and multiple ascending oral dose administration in healthy male subjects - MET409 SAD and MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45980

Enrollment

124

Registered

2018-04-16

Start date

2018-05-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Non-alcoholic steatohepatitis [NASH])

Interventions

Part A: The study will consist of 1 period during which you will receive MET409 or placebo as a single dose. MET409 and placebo will be given as oral tablets with 240 mL of tap water (or up to 480 m

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male subjects -18-65 years, inclusive, at screening -BMI 18.0-30.0 kg/m2, inclusive, at screening -Weight >=60 kg

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
-To assess the safety and tolerability of single and multiple oral doses of MET409. -To characterize the pharmacokinetics (PK) of single and multiple oral doses of MET409.	—

Secondary

Measure	Time frame
-To characterize the pharmacodynamics (PD) of single and multiple oral doses of MET409. -To identify the recommended multiple oral dose level(s) of MET409 for future studies in patients.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)