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

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: BI 473494; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03195088

2016-003224-24 (EudraCT Number)

1400-0001

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

BI 473494 35 μg

Experimental group

Description:

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

Treatment:

Drug: BI 473494

BI 473494 75 μg

Experimental group

Description:

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

Treatment:

Drug: BI 473494