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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01239771
First received: October 28, 2010
Last updated: June 27, 2012
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Elderly Subjects 65 Years and Older, Healthy or With a Stable Disease and Treatment.
Drug: TC-5214
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Adverse events [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Neurological examinations [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Visual acuity tests [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Physical examinations [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Suicidality as assessed by the Columbia-Suicide Severity Rating Scale [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: Range of 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic variables of TC-5214 by assessment of drug concentrations in plasma [ Time Frame: Range of 5 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TC-5214
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.
Placebo Comparator: 2
Placebo matched to TC-5214
Drug: Placebo
Two subjects in each cohort will be given placebo.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239771

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans A Eriksson, MD AstraZeneca
Principal Investigator: Wolfgang Kuhn, MD Quintiles Phase 1
Principal Investigator: Aslak Rautio, MD Quintiles Hermelinen
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01239771     History of Changes
Other Study ID Numbers: D4130C00013
Study First Received: October 28, 2010
Last Updated: June 27, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
stable disease
oral
tablet

ClinicalTrials.gov processed this record on July 31, 2014