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

Phase 1

Completed

• Conditions: Elderly Subjects 65 Years and Older, Healthy or With a Stable Disease and Treatment.
• Interventions: Drug: TC-5214; Drug: Placebo

• Registration Number: NCT01239771
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Status Verified: 2011-01
• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Medically stable male and female subjects aged greater than or equal to 65 years with suitable veins for cannulation or repeated venipuncture. Subjects may have controlled chronic diseases such as hypertension, type 2 diabetes, osteoarthritis, stable chronic obstructive pulmonary disease, mild or moderate renal insufficiency (Estimated glomerular filtration rate (eGFR) per the Modified Diet in Renal Disease [MDRD] formula >50 mL/min/1.73 m2), rhinitis etc. as long as there has not been any significant changes in their medical condition or medications for the preceding 6 weeks. Classification of renal impairment will be based using an MDRD equation
• Male subjects who are sexually active must use a condom and their partner if of childbearing potential must use a reliable method of contraception from the first dose of investigational product until 3 months after their last dose
• Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg

Exclusion Criteria

• History of any clinically significant medical, neurologic or psychiatric disease or disorder (other than those previously defined as acceptable for this population, see inclusion criterion 1) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study: This includes seizure activity and repeated episodes of major depression
• Significant cardiovascular or cerebrovascular disease such as: a history of acute coronary syndrome; angina that has been symptomatic in the last 6 months; significant symptomatic arrhythmia; a stroke; transient ischemic attack that have occurred in the last 6 months
• History or presence of gastrointestinal or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Subjects who have type 2 diabetes must have an HbA1c of less than 8% according to the National Glycohemoglobin Standardization Program (NGSP) at screening
• Significant renal insufficiency as defined by eGFR per the MDRD formula <50 mL/min/1.73 m2 (individual eGFR measurements will be documented in the protocol).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TC-5214	TC-5214
2	Placebo	Placebo matched to TC-5214

Primary Outcome Measures

Name	Time	Method
Neurological examinations	Range of 5 days
Visual acuity tests	Range of 5 days
Incidence of Adverse events	Range of 5 days
Vital signs	Range of 5 days
Physical examinations	Range of 5 days
Laboratory parameters	Range of 5 days
Suicidality as assessed by the Columbia-Suicide Severity Rating Scale	Range of 5 days
Electrocardiograms	Range of 5 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables of TC-5214 by assessment of drug concentrations in plasma	Range of 5 days

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden