A randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and food effect of orally administered LYC-30937 in healthy male subjects

Completed

• Conditions: colitis ulcerosa; Inflammatory bowel disease; 10003816

• Registration Number: NL-OMON41886
• Lead Sponsor: ycera Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 101

Inclusion Criteria

Age: 18-45 years
Gender: Male
BMI: 18.0-32.0 kg/m2

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>- Safety an tolerability: adverse events, vital signs including body<br /><br>temperature, ECG-parameters, continuous lead II electrocardiogram monitoring,<br /><br>laboratory parameters, physical examination.<br /><br>- Pharmacokinetic parameters<br /><br>- Food effect.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>