SINGLE-CENTER, OPEN-LABEL, SINGLE-DOSE STUDY OF THE EXCRETION BALANCE, PHARMACOKINETICS, AND METABOLISM OF 14C-LABELED UCB0599 AND UCB2713

SINGLE-CENTER, OPEN-LABEL, SINGLE-DOSE STUDY OF THE EXCRETION BALANCE, PHARMACOKINETICS, AND METABOLISM OF 14C-LABELED UCB0599 AND UCB2713 - Excretion balance and PK study of 14C UCB0599 and UCB2713

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43504

Enrollment

Registered

2015-11-17

Start date

2015-11-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Parkinson's Disease.

Interventions

The study will be performed in 2 parts in a total of 14 healthy male volunteers. Part A will consist of 8 volunteers. All 8 volunteers will receive 30 milligrams UCB1332 as 2 oral capsules. 4 volu

3 volunteers will receive 30 milligrams UCB1332 and a small dose of 20 micrograms of 14C UCB0599 as an intravenous infusion. 3 volunteers will receive 30 milligrams UCB1332 and a small dose of 20 m

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 55 years 50 - 100 kg BMI 18 - 30 kg/m2 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

Secondary

Measure	Time frame
• To determine the protein binding of total radioactivity, UCB0599 and UCB2713 and their respective desmethyl metabolites, in plasma and CSF, if permitted by analytical sensitivity (Part B) • To document the single dose safety and tolerability of UCB1332.	—

Primary

Measure	Time frame
Please refer to the protocol for more details, below the two main criteria: - To evaluate the excretion balance of 14C labeled UCB0599 and 14C labeled UCB2713 administered orally together with oral UCB1332 (Part A) - To evaluate the plasma and CSF PK profiles of UCB0599 and UCB2713 and their respective desmethyl metabolites when administered intravenously as 14C-labeled tracer together with an oral loading dose of UCB1332 (Part B)	—

Measure

Time frame

Please refer to the protocol for more details, below the two main criteria: - To evaluate the excretion balance of 14C labeled UCB0599 and 14C labeled UCB2713 administered orally together with oral UCB1332 (Part A) - To evaluate the plasma and CSF PK profiles of UCB0599 and UCB2713 and their respective desmethyl metabolites when administered intravenously as 14C-labeled tracer together with an oral loading dose of UCB1332 (Part B)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)