MedDataX Logo

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

NCT ID: NCT01145768

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

4 mg tablet, oral, BID, group 1

TC-5214

Intervention Type DRUG

TBD tablet, oral, BID, groups 2-6

2

Each cohort will have 3 volunteers that will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TC-5214

4 mg tablet, oral, BID, group 1

Intervention Type DRUG

TC-5214

TBD tablet, oral, BID, groups 2-6

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Donna Holloway

Role: STUDY_CHAIR

Quintiles, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Overland Park, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24408516 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D4130C00006

Identifier Type: -

Identifier Source: org_study_id