A DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED, SEQUENTIAL GROUP, MULTIPLE DOSE STUDY OF THE EFFICACY OF THE CRF1-RECEPTOR ANTAGONIST R317573 ON CCK-4 INDUCED ANXIETY IN HEALTHY MALE SUBJECTS. - N/A

Phase 1

Active, not recruiting

• Conditions: Anxiety and depression

• Registration Number: EUCTR2006-001475-38-NL
• Lead Sponsor: Janssen Cliag Ltd. C/O Johnson & Johnson PRD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-29
• Study Completion: 2007-02-27
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 0

Inclusion Criteria

1. Healthy males
2. Age between 18 and 45 years, inclusive
3. Willingness to use an adequate contraception for the duration of the study and for 3 months thereafter.
4. BMI between 18 and 28 kg/m2 inclusive (BMI = weight/height2).
5. Non-smoker (not smoked for 3 months prior to screening).
6. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
7. In order to participate in the pharmacogenomic component, subjects (or their legally acceptable representative) must have signed the informed consent for DNA research indicating whether they do or do not wish to participate in the DNA component of the study (where local regulations permit).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At screening and Day -3
1. Having cardiovascular disease or a history of cardiovascular disease.
2. Current psychiatric illness as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) and the medical history.
3. Clinically significant abnormal values in TSH measured during the screening period. It is expected that the values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance, are acceptable.
4. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to both the investigator and to the J&JPRD Safety Physician, are acceptable.
5. Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission.
6. History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson’s disease, infection, or any other illness that the Investigator considers should exclude the subject.
7. History of epilepsy or fits or unexplained black-outs.
8. Positive urine screen for drugs of abuse (opiates, barbiturates, cannabis, benzodiazepines, cocaine, amphetamines).
9. Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies 1 and 2.
10. Recent history (within previous 6 months) of alcohol or drug abuse.

On Day -2
1. Clinically significant abnormal values in the daytime ACTH/Cortisol concentrations on Day -2. It is expected that the values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance, are acceptable.

On Day -1
1. Insignificant response to the first CCK-4 challenge test defined as NOT HAVING a score greater than or equal to 2 of the symptom fear/anxiety/apprehension in the Panic Symptom Score (PSS) and NOT HAVING a score of greater than or equal to 1 of at least 4 of the 18 symptoms in the PSS.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified