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

NCT01239771 | Completed Phase 1

• 1 other identifier: D4130C00013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Safety; tolerability; healthy; stable disease; oral; tablet

Outcome Measures

Primary Outcomes (8)

• Incidence of Adverse events

  Range of 5 days

• Neurological examinations

  Range of 5 days

• Visual acuity tests

  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 Outcomes (1)

• Pharmacokinetic variables of TC-5214 by assessment of drug concentrations in plasma

  Range of 5 days

Study Arms (2)

1

EXPERIMENTAL

TC-5214

Drug: TC-5214

2

PLACEBO COMPARATOR

Placebo matched to TC-5214

Drug: Placebo

Interventions

TC-5214 DRUG

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

1

Placebo DRUG

Two subjects in each cohort will be given placebo.

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Uppsala County, Sweden

Location

Related Publications (1)

• Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.

  PMID: 24408516 DERIVED

Study Officials

• Hans A Eriksson, MD

  AstraZeneca

  STUDY DIRECTOR

• Wolfgang Kuhn, MD

  Quintiles Phase 1

  PRINCIPAL INVESTIGATOR

• Aslak Rautio, MD

  Quintiles Hermelinen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 11, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2011-01

Locations

SE (1)