AN OPEN-LABEL, SINGLE CENTRE TRIAL TO INVESTIGATE THE MASS BALANCE AND METABOLITE PROFILE OF A SINGLE ORAL DOSE OF AIC090019

Completed

• Conditions: Hepatitis B; 10047438; viral infection

• Registration Number: NL-OMON34410
• Lead Sponsor: AiCuris GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

- Healthy male
- 18-45 years of age, inclusive
- BMI 18.0-28.0 kg/m2
- Non-smoker or light to moderate smoker

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor (50 mL or more) 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. Participation is also not permitted when participated in more than 3 other drug studies in the 10 months prior to the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Radiokinetics<br /><br>- Pharmacokinetics<br /><br>- Safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>