Schizophrenia
Conditions
Keywords
receptors nicotinic
Brief summary
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
Detailed description
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.
Interventions
DRUGPharmacokinetic
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers: males and females who are incapable of pregnancy
Exclusion criteria
* Medical illnesses requiring acute treatment * History of seizures * Substance abuse including nicotine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Levels of Drug | 12 hours | This is the plasma level of the drug as determined by high performance liquid chromatography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacokinetic This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pharmacokinetic |
|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Blood Levels of Drug
This is the plasma level of the drug as determined by high performance liquid chromatography.
Time frame: 12 hours
Population: This is all participants in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacokinetic | Blood Levels of Drug | 1.5 ng/ml | Standard Deviation 0.7 |