To compare the pharmacokinetics of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function

Study identifier:D4130C00008

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Multi-Center, Phase I Study To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 (S-Mecamylamine) in Subjects with Renal Impairment with Subjects with Normal Renal Function

Medical condition

Healthy Volunteers, Patients, pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

TC-5214

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Nov 2010

Primary Completion Date: 01 Jul 2011

Study Completion Date: 01 Jul 2011

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: None
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Mar 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Males and non-pregnant, non-lactating females 18 to 80 years old inclusive with suitable veins for cannulation or repeated venipuncture with a weight of at least 50 kg.
- Regarding renal function, subjects will be classified as either normal or as suffering from mild, moderate or severe renal impairment. Classification of renal impairment will be based using an abbreviated 4 variable Modified Diet in Renal Disease (MDRD) equations. To ensure the assessment of consistent estimated glomerular filtration rate (eGFR) using the MDRD, a single equation will be used (see Section 6.2)
- Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen
- Regarding renal function, subjects will be classified as either normal or as suffering from mild, moderate or severe renal impairment. Classification of renal impairment will be based using an abbreviated 4 variable MDRD equation. To ensure the assessment of consistent estimated glomerular filtration rate (eGFR) using the MDRD, a single equation will be used.

Exclusion Criteria

- History of any clinically significant medical, neurologic or psychiatric disease or disorder (other than those previously defined as acceptable for these population) which, in the opinion of the Investigator and sponsor, 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.
- Subjects with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study
- Subjects with an active renal transplant (subjects who have previously received a renal transplant and are currently undergoing dialysis due to transplant failure may be enrolled)
- Any clinically significant acute illness or medical/surgical procedure within 4 weeks of the first administration of investigational product (IP) (other than those previously defined as acceptable for these population) as judged by the Investigator.
- Positive test in drugs of abuse screens (except for prescription medications, which are verified by the Investigator), or alcohol on admission to the clinic prior to the administration of the IP

No locations available

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1414&filename=CSR-D4130C00008.pdf
Download
CSR-D4130C00008.pdf
Download
D4130C00008/Clinical Study Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Hans A Eriksson

AstraZeneca