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

AN OPEN-LABEL, SINGLE CENTRE TRIAL TO INVESTIGATE THE MASS BALANCE AND METABOLITE PROFILE OF A SINGLE ORAL DOSE OF AIC090019 - AIC090019 mass balance/Met-ID trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34410

Enrollment

Registered

2010-09-20

Start date

2010-10-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Hepatitis B viral infection

Interventions

Active substance: AIC090019 and [14C]-AIC090019

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- Radiokinetics - Pharmacokinetics - Safety	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)