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

NCT ID: NCT02597998

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-15
• Study Completion Date: 2015-12-11

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

14C-BI 409306 - 25 mg

14C-BI 409306 oral solution

Group Type: EXPERIMENTAL

14C-BI 409306

Intervention Type: DRUG

Interventions

14C-BI 409306

Intervention Type: DRUG

Other Intervention Names

14C-BI 409306 oral solution

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2015-001877-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1289.26

Identifier Type: -

Identifier Source: org_study_id