A phase I, open-label study to investigate the absorption, metabolism, excretion, and mass balance of [14C]QLT091001 following single oral dose in healthy male subjects

A phase I, open-label study to investigate the absorption, metabolism, excretion, and mass balance of [14C]QLT091001 following single oral dose in healthy male subjects - RET HV 03

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35776

Enrollment

Registered

2011-03-31

Start date

2011-04-21

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

inherited retinal diseases

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG, vital signs). Furthermore a blood

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
To characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites.	—

Secondary

Measure	Time frame
To characterize the pharmacokinetics (PK) of the research medication and its major metabolites. To document the safety and tolerability.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)