A study to assess safety and tolerability as well as absorption and excretion of TC-5214 in medically stable elderly subjects

Study identifier:D4130C00013

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Elderly subjects 65 years and older, healthy or with a stable disease and treatment.

Phase

Phase 1

Healthy volunteers

Yes

Study drug

TC-5214, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

65 Years +

Date

Study Start Date: 01 Jan 2011

Primary Completion Date: 01 May 2011

Study Completion Date: 01 May 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and 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).

No locations available

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.

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1417&filename=CSR-D4130C00013.pdf
Download
CSR-D4130C00013.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Jan Stromborn

+46 (0)18 431 10 00

[email protected]

Investigators

Principal Investigator

Hans A Eriksson

AstraZeneca