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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02254161
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Matching placebo; Drug: BI 1181181 healthy elderly; Drug: BI 1181181 Healthy young	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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)
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1181181 healthy young Medium doses as tablets q.d. for 10 days	Drug: BI 1181181 Healthy young; Tablet
Experimental: BI 1181181 healthy elderly Medium doses as tablets q.d. for 10 days	Drug: BI 1181181 healthy elderly; Tablet
Placebo Comparator: Matching placebo in healthy young Matching placebo for 10 days	Drug: Matching placebo; Tablet
Placebo Comparator: Matching placebo in healthy elderly Matching placebo for 10 days	Drug: Matching placebo; Tablet

Outcome Measures

Primary Outcome Measures

1. frequency [N (%)] of subjects with drug-related adverse events [days 1 to 24]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

4. Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose [0 to 336 hours]

5. 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]

6. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1344.2.1 Boehringer Ingelheim Investigational Site	Berlin		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02254161
• Other Study ID Numbers: 1344.2; 2014-002482-30
• First Posted: Oct 1, 2014
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

Study Results

No Results Posted as of Aug 31, 2018