Copanlisib Mass Balance Study

Bayer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Copanlisib (BAY80-6946)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02119221

16353

2013-002544-90 (EudraCT Number)

Details and patient eligibility

About

The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.

Enrollment

6 patients

Sex

Male

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subject
Age: 45 to 65 years
Body weight greater or equal to 60 kg and body mass index (BMI): above/equal 18 and below/equal 30 kg/m²

Exclusion criteria

Regular use of medicines
Known recent (last 2 years) abuse of recreational drugs, suspicion of drug or alcohol abuse, or positive results of the drug and alcohol screen tests at screening or baseline
Use of strong inhibitors of cytochrome P450 (CYP)3A4, as well as use of St John's Wort or strong inducers of CYP3A4 prohibited from 14 days before the administration of study drug until discharge from the clinic
Smoking
Average intake of more than 24 units of alcohol per week; Regular daily consumption of more than 1 L of methylxanthine-containing beverages
Any condition, which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 2 days) constipation or symptomatic prostatic hypertrophy.
Participation in another mass balance study with a radiation burden > 0.1 mSv in the period of 1 year before screening