A Double-blind, Randomised, Two-way Cross-over, Single-dose, Placebo-controlled Trial to Investigate the Effects of BI 1358894 on Cholecystokinin Tetrapeptide (CCK-4) Induced Panic Symptoms in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- BI 1358894
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Maximum Change From Baseline in Panic Symptom Scale (PSS) Sum Intensity Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The main objective of this trial is to investigate the pharmacodynamic effects of a single dose of BI 1358894 on CCK-4- induced anxiogenic/ panic-like symptoms using the PSS in preselected CCK-4 sensitive healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- •Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception with their female partner throughout the study and until one month after the last administration of trial medication. Adequate methods are:
- •Sexual abstinence or
- •A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or
- •Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner or
- •Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L is confirmatory) or
- •The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide)
Exclusion Criteria
- •Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •C-Reactive Protein \>ULN, erythrocyte sedimentation rate (ESR) ≥15 millimeters/h, liver or kidney parameter above ULN,
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Chronic or relevant acute infections
Arms & Interventions
Treatment (T)
Intervention: BI 1358894
Reference Treatment (R)
Intervention: Placebo
Outcomes
Primary Outcomes
Maximum Change From Baseline in Panic Symptom Scale (PSS) Sum Intensity Score
Time Frame: Within 3 hours (h) prior trial medication administration and 4h, 4h 45 minutes (min), 5h 5min, 5h 10min, 5h 20min, 5h 30min and 192h thereafter.
The last value before administration of the CCK-4 challenge in each period was considered the corresponding period baseline measurement. The PSS sum intensity score mean value of the two period baseline values was considered as the subject baseline. The PSS is a patient reported outcome measurement from which the following factors where derived: physical symptoms of fear and the perception of alertness, anxiety, fear, and pain. The subjects were asked to rate each of 18 characteristic questions on a scale from 0 (absent) to 4 (very strong). The sum of the scale over all items constituted the PSS sum intensity score, ranging from 0 to 72. A higher score implies a stronger panic symptom.