EUCTR2010-023369-23-ES
Active, not recruiting
Phase 1
FIRST-IN-PATIENT STUDY TO ASSESS THE SAFETY ANDTOLERABILITYAND TO EXPLORE THE POTENTIAL THERAPEUTIC EFFICACY OF A NOVELGLUTAMATE MODULATOR AS MONOTHERAPY AND AS ADD-ON THERAPYIN PATIENTS WITH SCHIZOPHRENIA - NA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Janssen-Cilag International NV
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female between 18 and 65 years of age, inclusive
- •2\. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI \=
- •weight/height2\)
- •3\. Medically stable on the basis of physical examination, medical history,
- •vital signs and 12\-lead ECG performed at screening.
- •4\. Medically stable on the basis of clinical laboratory tests performed at
- •screening. If the results of the serum chemistry panel, hematology, or
- •urinalysis are outside the normal reference ranges, the subject may be
- •included only if the investigator judges the abnormalities or deviations
- •from normal to not be clinically significant or to be appropriate and
Exclusion Criteria
- •1\. A current DSM\-IV axis I diagnosis other than schizophrenia
- •2\. A DSM\-IV diagnosis of substance abuse or dependence within 6
- •months prior to screening evaluation (nicotine and caffeine dependence
- •are not exclusionary; subjects with a positive drug screen at screening
- •may be included provided use does not lead to a DSM\-IV diagnosis of
- •substance dependence and subjects should be encouraged to abstain
- •from alcohol and illegal drugs within 3 days prior to Day 1 and at any
- •time during the study)
- •3\. Any medical condition that could potentially alter the absorption,
- •metabolism, or excretion of the study medication, such as Crohn's
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Investigation of the safety , tolerability and potential therapeutic effects of JNJ-40411813 in patients with schizophreniaSchizophreniaMedDRA version: 14.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2010-023369-23-BEJanssen-Cilag International NV105
Active, not recruiting
Not Applicable
FIRST-IN-PATIENT STUDY TO ASSESS THE SAFETY AND TOLERABILITY AND TO EXPLORETHE POTENTIAL THERAPEUTIC EFFICACY OF A NOVEL GLUTAMATE MODULATOR ASMONOTHERAPY AND AS ADD-ON THERAPY IN PATIENTS WITH SCHIZOPHRENIA - N/ASchizophreniaMedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaEUCTR2010-023369-23-ATJanssen-Cilag International NV105
Active, not recruiting
Not Applicable
Investigation of the safety , tolerability and potential therapeutic effects of JNJ-40411813 in patients with schizophreniaEUCTR2010-023369-23-DEJanssen-Cilag International NV105
Active, not recruiting
Not Applicable
Investigation of the safety , tolerability and potential therapeutic effects of JNJ-40411813 in patients with schizophreniaSchizophreniaMedDRA version: 15.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2010-023369-23-BGJanssen-Cilag International NV105
Not yet recruiting
Phase 1
Salmonella Vaccine Immunogenicity and Safety (SaVIS) StudyPACTR202310834458532niversity of Oxford120