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Completed

NCT Number: NCT01392820

A Study 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.

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Key information

Conditions

Healthy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TC-5214

Drug

Tablet, Oral, twice daily

Placebo

Drug

Tablet, Oral, twice daily

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.

    Time frame: 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.

    Time frame: PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 13, 2011
Registry last updated
Nov 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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