Trial Outcomes & Findings for Nicotinic Receptors and Schizophrenia (NCT NCT00952393)

Last Updated: 2016-02-05

Results Overview

This is the plasma level of the drug as determined by high performance liquid chromatography.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

12 hours

Results posted on

2016-02-05

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Nicotinic Receptors and Schizophrenia

Baseline characteristics by cohort
Measure	Pharmacokinetic n=10 Participants 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
Age, Continuous	31.7 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

Timeframe: 12 hours

Population: This is all participants in the study.

This is the plasma level of the drug as determined by high performance liquid chromatography.

Outcome measures
Measure	Pharmacokinetic n=10 Participants 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
Blood Levels of Drug	1.5 ng/ml Standard Deviation 0.7

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Colorado

Phone: 3037244940