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

NCT ID: NCT01392820

Last Updated: 2011-11-15

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TC-5214

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

Tablet, Oral, twice daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, Oral, twice daily

Interventions

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TC-5214

Tablet, Oral, twice daily

Intervention Type DRUG

Placebo

Tablet, Oral, twice daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Eriksson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Shunji Matsuki, MD

Role: PRINCIPAL_INVESTIGATOR

Kyushu Clinical Pharmacology Research Clinic

Locations

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Research Site

Fukuoka, Fukuoka, Japan

Site Status

Countries

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Japan

References

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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

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D4131C00003

Identifier Type: -

Identifier Source: org_study_id