A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LNP023 following a single oral dose of [14C]LNP023 in healthy male/female subjects.

A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LNP023 following a single oral dose of [14C]LNP023 in healthy male/female subjects. - ADME of LNP023 following a single oral dose of [14C]LNP023

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48316

Enrollment

Registered

2019-06-17

Start date

2019-06-17

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

auto-immune diseases

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male / female of non-childbearing potential 18 - 55 years more than 50 kilograms. BMI 18.0 - 30.0 kilograms / meter2

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 characterize the plasma pharmacokinetics (PK) of LNP023 and key metabolites, if applicable. To determine the PK of total radioactivity in blood and plasma. To determine the rates and routes of excretion of [14C]LNP023-related radioactivity, including mass balance of total drug-related radioactivity in urine and feces following a single 100-mg oral dose of [14C]LNP023 in healthy volunteers (HV).	—

Measure

Time frame

To characterize the plasma pharmacokinetics (PK) of LNP023 and key metabolites, if applicable. To determine the PK of total radioactivity in blood and plasma. To determine the rates and routes of excretion of [14C]LNP023-related radioactivity, including mass balance of total drug-related radioactivity in urine and feces following a single 100-mg oral dose of [14C]LNP023 in healthy volunteers (HV).

—

Secondary

Measure	Time frame
To assess the safety and tolerability of a single 100-mg oral dose of [14C]LNP023 administered to HV.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)