Status:
COMPLETED
The Effect of Nicotine on Arousal, Cognition and Social Cognition in Young and Elderly Healthy Subjects.
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Collaborating Sponsors:
Agentschap voor Innovatie door Wetenschap en Technologie
Conditions:
Schizophrenia
Cognition Disorders
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
This study in young and elderly healthy subjects will investigate the effect of nicotine on arousal, cognitive task and social cognition after acute dose administration.
Detailed Description
This is a double-blind (neither physician nor subject knows the name of the assigned drug), placebo-controlled, randomized (study drug assigned by chance), three-way-crossover trial (participants may ...
Eligibility Criteria
Inclusion
- Man or woman between 18 and 30 years of age inclusive (Cohort 1 only)
- Man or woman between 60 and 75 years of age, inclusive (Cohort 2 only)
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive (BMI = eight/height2)
- Women must be: postmenopausal (for at least 12 months), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control and must agree to continue to use the same method of contraception throughout the study
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission (each study period)
- Men must agree to use a condom at each sexual intercourse and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration
Exclusion
- Female volunteers who are pregnant or breastfeeding
- Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening. 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 the investigator, are acceptable. Values of alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 2 fold Upper Limit of Normal will be allowed
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening
- History of epilepsy or fits or unexplained black-outs
- Current dangerous or aggressive behavior
- Clinically significant history of drug and/or food allergies
- Recent history (within previous 6 months) of alcohol or drug abuse
- Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant should exclude the subject (Subjects with well-controlled hypertension will be allowed to participate)
- Significant history of or current psychiatric or neurological illness
- Smoking cigarettes (or equivalent) or the use of nicotine based products, within 3 months prior to study drug administration. Current use of any medication for smoking cessation such as nicotine replacement therapy, bupropion or varenicline
- Positive urine screen for drugs of abuse at screening or admission
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01181934
Start Date
May 1 2010
End Date
February 1 2011
Last Update
March 20 2012
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