Nicotinic Receptors and Schizophrenia
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Blood Levels of Drug
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Pharmacokinetic
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Intervention: Pharmacokinetic (Drug)
Outcomes
Primary Outcomes
Blood Levels of Drug
Time Frame: 12 hours
This is the plasma level of the drug as determined by high performance liquid chromatography.
Secondary Outcomes
No secondary outcomes reported