A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LOU064 following a single dose of [14C]LOU064 administered orally or intravenouslyl in healthy male and female subjects at steady-state.

A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LOU064 following a single dose of [14C]LOU064 administered orally or intravenouslyl in healthy male and female subjects at steady-state. - ADME of LOU064 following a single dose of [14C]LOU064

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49324

Enrollment

Registered

2019-07-24

Start date

2019-08-29

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

autoimmune and chronic inflammatory diseases

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female of non-childbearing potential. 18 - 55 years of age. BMI 18.0 - 30.0 kilograms/meter2 non smokers

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
To determine the rates and routes of excretion of [14C]LOU064-related radioactivity, including mass balance of total drug-related radioactivity in urine and feces. To determine the pharmacokinetics (PK) of total radioactivity in blood and plasma of [14C]LOU064. To characterize the blood PK of LOU064 and known key metabolites, if applicable.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of multiple oral doses of 100 mg of LOU064 administered to healthy male/female subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)