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

Healthy Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254161
• Other study ID #: 1344.2
• Secondary ID: 2014-002482-30
• Status: Terminated
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Matching placebo
Tablet
• BI 1181181 healthy elderly
Tablet
• BI 1181181 Healthy young
Tablet

Locations

Country	Name	City	State
Germany	1344.2.1 Boehringer Ingelheim Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency [N (%)] of subjects with drug-related adverse events		days 1 to 24
Secondary	Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose		0 to 336 hours
Secondary	Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose		0 to 336 hours
Secondary	AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)		0 to 336 hours
Secondary	Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose		0 to 336 hours
Secondary	AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose		0 to 336 hours
Secondary	AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose		0 to 336 hours