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CompletedNCT01145768Updated Dec 8, 2010

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

A Phase 1 interventional study of TC-5214 and TC-5214 in Healthy, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-08.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Double-blind
  • randomized
  • placebo-controlled
  • parallel-group study
  • Safety
  • pharmacokinetics
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    1

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

    Drug: TC-5214

  • Placebo comparator
    2

    Each cohort will have 3 volunteers that will receive placebo

    Drug: Placebo

Interventions

  • DrugTC-5214

    4 mg tablet, oral, BID, group 1

  • DrugTC-5214

    TBD tablet, oral, BID, groups 2-6

  • DrugPlacebo
06

What researchers measure

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

    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.

Secondary outcomes

  1. 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.

  2. 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

07

Study locations

1 site
  • Research Site
    Overland Park, Kansas, United States
08

References and documents

Publications

  • 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. PubMed 24408516 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01145768
Lead sponsor
AstraZeneca
First posted
Jun 17, 2010
Start date
Jun 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Dec 8, 2010

Study contacts

David Mathews, MD
principal investigator · Quintiles, Inc.
Donna Holloway
study chair · Quintiles, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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