A Study in Healthy Men to Test How BI 730357 is Processed by the Body

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03664011
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The main objectives of the study are as follows:

• To assess the mass balance recovery of [14C]-radioactivity in urine and faeces after a single oral dose of 50 mg BI 730357 BS (C-14) in healthy male subjects

• To provide plasma, urine, and faecal samples for metabolite profiling and structural identification

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 730357 mixed with [C-14]BI 730357 BS	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I, Open-label, Single-dose Trial to Investigate Metabolism and Pharmacokinetics of BI 730357 BS (C-14) Administered as Oral Solution in Healthy Male Volunteers
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Nov 13, 2018
• Actual Study Completion Date: Nov 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Subjects	Drug: BI 730357 mixed with [C-14]BI 730357 BS; Oral Solution

Outcome Measures

Primary Outcome Measures

1. feurine, 0-t2 (fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to t2 (where t2 is the last quantifiable data point across all subjects)) [Up to 7 weeks]

2. fefaeces, 0-t2 (fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to t2 (where t2 is the last quantifiable data point across all subjects)) [Up to 7 weeks]

Secondary Outcome Measures

1. Cmax (maximum measured concentration of the analyte) [Up to 7 weeks]

2. AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) [Up to 7 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests

• Age of 18 to 65 years (incl.)

• BMI of 18.5 to 29.9 kg/m2 (incl.)

• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

• Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:

• Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g. implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or

• Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or

• Condoms plus surgically sterilised partner (including hysterectomy) or

• Condoms plus intrauterine device or

• Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner to the study drug via seminal fluid. Male and female condoms must not be used together. Alternatively, true abstinence is acceptable when it is in line with the subjec's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above.

Exclusion Criteria:

• Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator

• Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 bpm.

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease judged as clinically relevant by the investigator

• Clinically significant gastrointestinal (including known or suspected inflammatory bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• Further exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences Onderzoekscentrum Martini	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03664011
• Other Study ID Numbers: 1407-0031; 2018-001837-41
• First Posted: Sep 10, 2018
• Last Update Posted: Nov 19, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 19, 2018