To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240967
• Other study ID #: D4130C00008
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2010
• Last updated: March 14, 2014
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers
• Patients
• Pharmacokinetics
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• TC-5214
Oral tablets, single dose

Locations

Country	Name	City	State
United States	Research site	Minneapolis	Minnesota
United States	Research Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetics (PK) of a single dose of TC-5214 in subjects with renal impairment in comparison to the results in subjects with normal renal function		For Group 1, Group 2, and Group 3 blood PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose.	No
Primary	The pharmacokinetics (PK) of a single dose of TC-5214 in subjects with renal impairment in comparison to the results in subjects with normal renal function	If study procedures for any subjects in Group 4 are extended by 24 hours to Day 5, PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose.	For Group 4 blood PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose.	No
Secondary	The effect of hemodialysis on TC-5214 pharmacokinetics		For Group 5 blood PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose.	No
Secondary	Safety and tolerability variables: Adverse events and serious adverse events (including severity), vital signs, physical examinations, laboratory parameters, electrocardiograms, and the Columbia-Suicide Severity Rating Scale.		A range of 5 days -from Screening to follow-up visit.	Yes

External Links

•   Link
•   CSR-D4130C00008.pdf
•   D4130C00008/Clinical Study Protocol