Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1181181 healthy elderly; Drug: Matching placebo; Drug: BI 1181181 Healthy young

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254161

1344.2

2014-002482-30 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
2. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
3. BMI of 18.5 to 29.9 kg/m2 (incl.)
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 BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
3. Any evidence of a concomitant disease judged as clinically relevant by the investigator
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
6. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

BI 1181181 healthy young

Experimental group

Description:

Medium doses as tablets q.d. for 10 days

Treatment:

Drug: BI 1181181 Healthy young

BI 1181181 healthy elderly

Experimental group

Description:

Medium doses as tablets q.d. for 10 days

Treatment:

Drug: BI 1181181 healthy elderly

Matching placebo in healthy young

Placebo Comparator group

Description:

Matching placebo for 10 days

Treatment:

Drug: Matching placebo

Matching placebo in healthy elderly

Placebo Comparator group

Description:

Matching placebo for 10 days

Treatment:

Drug: Matching placebo