Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers

NCT02106247 | Completed Phase 1

• 2 other identifiers: 1344.202013-004563-32
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• %-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM)

  up to 24 h

Secondary Outcomes (3)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid over the time interval from 0 to the last quantifiable data point)

  up to 72 h

• Cmax (maximum measured concentration of the analyte in plasma and cerebrospinal fluid)

  up to 72 h

• AUC0-infinity (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid (if possible) over the time interval from 0 extrapolated to infinity)

  up to 72 h

Study Arms (3)

1 BI 1181181 low dose

EXPERIMENTAL

tablet

Drug: BI 1181181 low dose

BI 1181181 high dose

EXPERIMENTAL

tablet

Drug: BI 1181181 high dose

Placebo

EXPERIMENTAL

tablet

Drug: Placebo

Interventions

BI 1181181 high dose DRUG

two tablet

BI 1181181 high dose

BI 1181181 low dose DRUG

one tablet

1 BI 1181181 low dose

Placebo DRUG

tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the investigator´s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age 18 to 50 years (incl.)
• BMI 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
• Repeated measurement of systolic blood pressure \< 90 mmHg and \>= 140 mmHg at screening in supine position
• Repeated measurement of diastolic blood pressure \< 55 and \>= 90 mmHg at screening in supine position
• Repeated measurement of pulse rate \< 40 bpm and \> 90 bpm at screening
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• Positive testing on infectious diseases
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (\>24 hours) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1344.20.32001 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 10, 2014

Record last verified: 2014-07

Locations

BE (1)