Copanlisib Mass Balance Study

Phase 1CompletedNCT02119221

Bayer6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Copanlisib (BAY80-6946)DRUG

Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of \[14C\]

Eligibility

Sex: MALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Zuidlaren, Netherlands