Anxiety and stress disorders
Conditions
Interventions
JNJ-613932, alprazolam or placebo.
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects between 18 and 55 years of age, inclusive.;2. Subjects must have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive (BMI = weight/height2).;3. Subject must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [incl. QTcF 40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12
Exclusion criteria
Exclusion criteria: 1. Subject has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable.;2.1 Current or past history of any psychiatric disorder as classified according to DSM-IV or DSM-V.;3.1 Subject has any liver function test (including ALT, AST, gGT, ALP and bilirubin) at screening exceeding 1.5 times the upper limit of normal.;4. Subject has estimated glomerular filtration rate (eGFR) 100 bpm or systolic blood pressure >= 150 mmHg at screening or at admission to the clinical unit.;Specific exclusion criteria Part 2: - Contraindications to the use of alprazolam per local prescribing information.;- Subject has a personal or family history of sickle cell anaemia.;- Subject has a history of benzodiazepines abuse and/or dependence.;- Subject has a significant cardiovascular history, or suspicion of infarct, cardiomyopathy, cardiac failure, transient ischaemic attack, angina pectoris, cardiac arrhythmias, cerebrovascular accident.;- Subject has a history of significant respiratory conditions, including asthma, lung fibrosis and non-invalidating Chronic Obstructive Pulmonary Disease.;- Subject has a personal or familial history of cerebral aneurysm.;- Subject has hypertension (i.e. systolic pressure >180 and/or diastolic pressure >100mmHg).;- Subject has epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations; 2. Pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations; 3. The effect of JNJ-61393215 on subjective fear and anxiety symptoms elicited by 35% CO2 double breath inhalation challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of JNJ-61393215 on physiological response on 35% CO2 double breath inhalation challenge (i.e. changes in blood pressure and heart rate); 2. Effect of JNJ-61393215 on the startle potentiation in the unpredictable shock condition during the fear potentiated startle test; 3. Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale. | — |
Countries
Netherlands
Outcome results
None listed