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

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 - LYC-30937 SAD MAD FE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41886

Enrollment

101

Registered

2014-03-13

Start date

2015-04-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

colitis ulcerosa Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Countries

Netherlands

Outcome results