Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 14C-BI 409306

Study type: Interventional

Funder types: Industry

Identifiers

NCT02597998

2015-001877-42 (EudraCT Number)

1289.26

Details and patient eligibility

About

The aim of this study is to assess the mass balance recovery from excreta of carbon 14 labelled BI409306 ([14C] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male genotyped as CY2C19 poor metabolizer (PM) or extensive metabolizer (EM) according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrogardiogramm), and clinical laboratory tests. PM is defined as carrier of two non-functional alleles *2 and *3 of the CYP2C19 gene (diplotypes *2/*2; *2/*3; *3/*3). EM is defined as carrier of two functional alleles of the CYP2C19 gene (absence of *2, *3, *17; diplotype *1/*1).
2. Age of 30 to 65 years (incl.).
3. BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.).
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
5. A history of regular bowel movements (averaging 1 or more bowel movements per day; subjects with regular bowel movements of >3 per day will be excluded).
6. Subjects who are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 90 days after the last dose of IMP.

Exclusion criteria

1. Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogramm) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. Any significant history of ocular or eye disease.
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

14C-BI 409306 - 25 mg

Experimental group

Description:

14C-BI 409306 oral solution

Treatment:

Drug: 14C-BI 409306