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A Study to Assess Safety and Tolerability as Well as Absorption and Excretion of TC-5214 in Medically Stable Elderly Subjects

NCT01239771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-06-28

No results posted yet for this study

Summary

The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214 in medically stable elderly subjects following multiple oral doses.

Conditions

  • Elderly Subjects 65 Years and Older, Healthy or With a Stable Disease and Treatment.

Interventions

DRUG

TC-5214

Tablet 1, 2, or 4 mg of TC-5213 will be given twice daily for 4 days and once on the 5th day.

DRUG

Placebo

Two subjects in each cohort will be given placebo.

Sponsors & Collaborators

Principal Investigators

  • Hans A Eriksson, MD · AstraZeneca

  • Wolfgang Kuhn, MD · Quintiles Phase 1

  • Aslak Rautio, MD · Quintiles Hermelinen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239771 on ClinicalTrials.gov