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
Completed
- Conditions
- Non-alcoholic steatohepatitis [NASH])10019654
- Registration Number
- NL-OMON45980
- Lead Sponsor
- Metacrine, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-To assess the safety and tolerability of single and multiple oral doses of<br /><br>MET409.<br /><br><br /><br>-To characterize the pharmacokinetics (PK) of single and multiple oral doses of<br /><br>MET409.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-To characterize the pharmacodynamics (PD) of single and multiple oral doses of<br /><br>MET409.<br /><br><br /><br>-To identify the recommended multiple oral dose level(s) of MET409 for future<br /><br>studies in patients.</p><br>