Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects

NCT ID: NCT03195088

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2017-11-14

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.

The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for injection

BI 473494 35 μg

Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.

Group Type: EXPERIMENTAL

BI 473494

Intervention Type: DRUG

Solution for injection

BI 473494 75 μg

Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.

Group Type: EXPERIMENTAL

BI 473494

Intervention Type: DRUG

Solution for injection

Interventions

BI 473494

Solution for injection

Intervention Type: DRUG

Placebo

Solution for injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects according to the assessment of the investigator, 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 45 years (incl.)
• Body Mass Index [BMI] of 20.0 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice [GCP] and local legislation

Exclusion Criteria

• Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [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 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
• 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: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Mannheim GmbH

Mannheim, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003224-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1400-0001

Identifier Type: -

Identifier Source: org_study_id