A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT03804671

Collaborator

(none)

Enrollment

Location

Arm

1.8

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 730357 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:

Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 730357 Administered as an Oral Dose With an Intravenous Microtracer Dose of BI 730357 BS (C-14) in Healthy Male Volunteers

Actual Study Start Date :

Jan 31, 2019

Actual Primary Completion Date :

Mar 26, 2019

Actual Study Completion Date :

Mar 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Subjects Test treatment T followed by Reference treatment R	Drug: BI 730357 Oral dose Drug: BI 730357 mixed with [C-14] BI 730357 BS Intravenous dose

Arm

Intervention/Treatment

Experimental: All Subjects

Test treatment T followed by Reference treatment R

Drug: BI 730357

Oral dose

Drug: BI 730357 mixed with [C-14] BI 730357 BS

Intravenous dose

Outcome Measures

Primary Outcome Measures

[C-14]BI 730357 BS AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 to infinity) [Up to Day 8]
BI 730357 AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 to infinity) [Up to Day 8]

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, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 65 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Further inclusion criteria apply

Exclusion Criteria:

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed 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 assessed 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
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

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT03804671

Other Study ID Numbers:

1407-0033
2018-003103-19

First Posted:

Jan 15, 2019

Last Update Posted:

Mar 19, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 19, 2020