To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days - Full Text View

Purpose

To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.

Condition	Intervention	Phase
Healthy	Drug: TC-5214 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 1, Single Center, Double-blind, Randomized, Placebo- Controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TC-5214 (S-Mecamylamine) After Administration of Single and Multiple Ascending Doses for up to 8 Days in Healthy Male and Female Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs [ Time Frame: Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To characterize the pharmacokinetics of TC-5214 in blood and urine after single and repeated oral doses by collecting blood and urine samples to measure drug concentration levels [ Time Frame: Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11. ] [ Designated as safety issue: Yes ]
To assess the effect of food on the pharmacokinetics of TC-5214 following oral administration by collecting blood and urine samples to measure drug concentration levels. [ Time Frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	June 2010
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Each cohort will have 9 volunteers that will receive TC-5214	Drug: TC-5214 4 mg tablet, oral, BID, group 1 Drug: TC-5214 TBD tablet, oral, BID, groups 2-6
Placebo Comparator: 2 Each cohort will have 3 volunteers that will receive placebo	Drug: Placebo

Eligibility

Criteria

Inclusion Criteria:

Male and nonpregnant, nonlactating female, with suitable veins for cannulation or repeated venipuncture
Contraceptive use from the first dose of investigational product until12 weeks after their last dose
Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results of
History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or unintentional rapid weight loss
Volunteers with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145768

Locations

United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	David Mathews, MD	Quintiles
Study Chair:	Donna Holloway	Quintiles

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01145768 History of Changes
Other Study ID Numbers:	D4130C00006
Study First Received:	June 7, 2010
Last Updated:	December 6, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Double-blind
randomized
placebo-controlled

parallel-group study
Safety
pharmacokinetics

ClinicalTrials.gov processed this record on June 18, 2013