A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of ZPL389 following a single oral dose of [14C]ZPL389 in healthy male subjects.

A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of ZPL389 following a single oral dose of [14C]ZPL389 in healthy male subjects. - ADME ZPL389

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46218

Enrollment

Registered

2018-10-03

Start date

2018-10-16

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

atopic dermatitis

Interventions

100 mg radioactive labeled ZPL389 will be given as oral capsules with 240 milliliters (mL) of (tap) water. During the first 4 hours after administration of the study compound the volunteer is not

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subjects 18-55 yrs, inclusive BMI: 18.0-30.0 kg/m2 Weigth at least 50kg Non-smoking

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] ZPL389 - related radioactivity, including mass balance of total drug-related radioactivity in urine and feces. To determine the pharmacokinetics of total radioactivity in blood and plasma. To characterize the plasma pharmacokinetics of ZPL389.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of a single 100 mg oral dose of [14C] ZPL389 administered to healthy male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)