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

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-05-31

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

TC-5214

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

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

2

Placebo matched to TC-5214

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two subjects in each cohort will be given placebo.

Interventions

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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.

Intervention Type DRUG

Placebo

Two subjects in each cohort will be given placebo.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes