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

NCT01145768 | Completed Phase 1

• 1 other identifier: D4130C00006
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Double-blind; randomized; placebo-controlled; parallel-group study; Safety; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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

  Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events.

Secondary Outcomes (2)

• 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

  Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11.

• 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.

  Samples taken during the residential period at defined timepoints pre-dose and post-dose

Study Arms (2)

1

EXPERIMENTAL

Each cohort will have 9 volunteers that will receive TC-5214

Drug: TC-5214

2

PLACEBO COMPARATOR

Each cohort will have 3 volunteers that will receive placebo

Drug: Placebo

Interventions

TC-5214 DRUG

4 mg tablet, oral, BID, group 1

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

• Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.

  PMID: 24408516 DERIVED

Study Officials

• David Mathews, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

• Donna Holloway

  Quintiles, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 17, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

US (1)