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

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AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: TC-5214
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01392820
D4131C00003

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

48 participants in 2 patient groups, including a placebo group

TC-5214
Experimental group
Treatment:
Drug: TC-5214
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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