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A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392820
First received: July 11, 2011
Last updated: November 14, 2011
Last verified: November 2011

July 11, 2011
November 14, 2011
July 2011
October 2011   (final data collection date for primary outcome measure)
assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS. [ Time Frame: During the whole study period, ca. 50 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01392820 on ClinicalTrials.gov Archive Site
characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers. [ Time Frame: PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Drug: TC-5214
    Tablet, Oral, twice daily
  • Drug: Placebo
    Tablet, Oral, twice daily
  • Experimental: TC-5214
    Intervention: Drug: TC-5214
  • Placebo Comparator: 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
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese healthy elderly male and female ≥65 years old.
  • Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.
  • Be able to understand and comply with the requirements of the study as judged by the investigator(s).

Exclusion Criteria:

  • History of any clinically significant medical or neurologic disease or disorder.
  • History of gastrointestinal surgery or unintentional rapid weight loss.
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01392820
D4131C00003
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Hans Eriksson, MD AstraZeneca
Principal Investigator: Shunji Matsuki, MD Kyushu Clinical Pharmacology Research Clinic
AstraZeneca
November 2011

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