To Investigate Safety, Tolerability and Pharmacokinetics of TC-5214 in Healthy Male Japanese Subjects

NCT01175564 | Completed Phase 1

• 1 other identifier: D4131C00002
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess safety, tolerability and pharmacokinetics after a single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.

Conditions

Healthy

Keywords

TC-5214; safety; pharmacokinetics; single dose; repeated dose; Japanese; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Safety by assessment of adverse events, brief neurological examinations, visual acuity test, vital signs, physical examinations, laboratory parameters, and electrocardiograms (ECGs), and Columbia Suicide Severity Rating Scale (C-SSRS).

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

Secondary Outcomes (2)

• Under Single Dosing conditions: Cmax, tmax, λz, t½λz, AUC(0-12), AUC(0-t), AUC, AUMC, MRT, % AUC extrapolated, CL/F, Vss/F, Ae fraction, Fe, (% of dose) Renal CLR.

  Blood samples are taken repeatedly for 24 hours after dosing for 24 hours on Day 1 for SAD

• Under Multiple Dosing Conditions: Css, max, Cmin, Cmax (tss,max), λz, t½λz, AUCss, AUC(0-t), AUC, AUMC, MRT, % AUC extrapolated, CL/F, Vss/F, Ae, Fe % of dose,Renal CLR, Rac(Cmax), Rac(AUC), Rac(Cmin)), LI, % fluctuation, time to reach the steady state

  Blood samples are taken repeatedly for 24 hours after dosing for 24 hours on Day 1 for SAD and Day 6 (last dose) for MAD.

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: TC-5214

Placebo

PLACEBO COMPARATOR

Each cohort will have 3 volunteers that will receive placebo

Drug: Placebo

Interventions

TC-5214 DRUG

Four increasing doses levels of a single dose and two increasing dose levels of 6 days repeated dose of TC-5214 tablet

Active

Placebo DRUG

Placebo tablet, single dose and 6 days repeated dose

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese Healthy male ≥20 and ≤55 years old inclusive with suitable veins for cannulation or repeated venipuncture
• Have a body mass index (BMI) of ≥18 and ≤27 kg/m2 and weigh at least 50 kg

You may not qualify if:

• History of any clinically significant medical or neurologic disease or disorder which, in the opinion of the investigator and sponsor, may either put the subject at risk because of participation in the study, or influence the results of the subject's
• History of psychiatric disorders
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.

Sponsors & Collaborators

• AstraZeneca: lead

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

• Hans Eriksson

  AstraZeneca R&D Sodertalje, SE-151 85 Sodertalje, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: August 5, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 6, 2013

Record last verified: 2013-02