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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01175564
First received: July 23, 2010
Last updated: February 5, 2013
Last verified: February 2013

July 23, 2010
February 5, 2013
July 2010
September 2010   (final data collection date for primary outcome measure)
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). [ Time Frame: Collected prior to treatment, during treatment and 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01175564 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: Blood samples are taken repeatedly for 24 hours after dosing for 24 hours on Day 1 for SAD ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
To Investigate Safety, Tolerability and Pharmacokinetics of TC-5214 in Healthy Male Japanese Subjects
A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of a Single Dose and Multiple Doses of TC-5214 (S-Mecamylamine) in Healthy Male Japanese Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: TC-5214
    Four increasing doses levels of a single dose and two increasing dose levels of 6 days repeated dose of TC-5214 tablet
  • Drug: Placebo
    Placebo tablet, single dose and 6 days repeated dose
  • Experimental: Active
    Each cohort will have 9 volunteers that will receive TC-5214
    Intervention: Drug: TC-5214
  • Placebo Comparator: Placebo
    Each cohort will have 3 volunteers that will receive placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01175564
D4131C00002
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Hans Eriksson AstraZeneca R&D Sodertalje, SE-151 85 Sodertalje, Sweden
AstraZeneca
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP