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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01239771
• Date of registration: 28/10/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study to Assess Safety and Tolerability as Well as Absorption and Excretion of TC-5214 in Medically Stable Elderly Subjects
• Scientific title: A Phase I, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of TC-5214 Given as Multiple Ascending Oral Doses in Medically Stable Elderly Subjects
• Date of first enrolment: January 2011
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01239771
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Sweden

Contacts

• Name: Wolfgang Kuhn, MD
• Affiliation: Quintiles Phase 1

• Name: Aslak Rautio, MD
• Affiliation: Quintiles Hermelinen

• Name: Hans A Eriksson, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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).



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: Placebo

Drug: TC-5214

Primary Outcome(s)

Laboratory parameters [Time Frame: Range of 5 days]

Visual acuity tests [Time Frame: Range of 5 days]

Neurological examinations [Time Frame: Range of 5 days]

Incidence of Adverse events [Time Frame: Range of 5 days]

Physical examinations [Time Frame: Range of 5 days]

Electrocardiograms [Time Frame: Range of 5 days]

Suicidality as assessed by the Columbia-Suicide Severity Rating Scale [Time Frame: Range of 5 days]

Vital signs [Time Frame: Range of 5 days]

Secondary Outcome(s)

Pharmacokinetic variables of TC-5214 by assessment of drug concentrations in plasma [Time Frame: Range of 5 days]

Secondary ID(s)

D4130C00013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors