A two-period microdosing study to determine the single-dose pharmacokinetics of ITMN-8187 after intravenous and oral administration in healthy subjects.

A two-period microdosing study to determine the single-dose pharmacokinetics of ITMN-8187 after intravenous and oral administration in healthy subjects. - [14C]-ITMN-8187 microdose study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34901

Enrollment

Registered

2010-02-15

Start date

2010-02-23

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 C virus

Interventions

Active substance: ITMN-8187 (radiolabeled)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male volunteers - age between 18 and 65 years - BMI is between 18.0 and 32.0 kg/m2 - non smoker or light or moderate smoker, i.e. * 5 cigarettes a day - at screening the state of health must satisfy the entry requirements

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 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
Pharmacokinetics Safety	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)