Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1034020; Drug: Placebo to BI 1034020

Study type: Interventional

Funder types: Industry

Identifiers

NCT01958060

1312.1

2011-004615-23 (EudraCT Number)

Details and patient eligibility

About

Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020

Enrollment: 35 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age within the range of 18 to 40 years
3. Body mass index within the range of 18.5 and 29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria

1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement
2. Any evidence of a clinically relevant concomitant disease.
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
4. Surgery of the gastrointestinal tract (except appendectomy).
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 2 patient groups

BI 1034020 intravenous part

Experimental group

Description:

single rising doses

Treatment:

Drug: BI 1034020

Drug: Placebo to BI 1034020

BI 1034020 subcutaneous part

Experimental group

Description:

single rising doses

Treatment:

Drug: BI 1034020

Drug: Placebo to BI 1034020