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
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 15, 2011
November 1, 2011
3 months
July 11, 2011
November 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
During the whole study period, ca. 50 days
Secondary Outcomes (1)
characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers.
PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part.
Study Arms (2)
TC-5214
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Fukuoka, Fukuoka, Japan
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: 24408516DERIVED
Study Officials
- STUDY DIRECTOR
Hans Eriksson, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Shunji Matsuki, MD
Kyushu Clinical Pharmacology Research Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 15, 2011
Record last verified: 2011-11