Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214

Healthy Subjects Clinical Trial

— TC-5214  

Official title:

Phase I, Open-label, Randomized, Single-dose, Two Treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458899
• Other study ID #: D4130C00025
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2011
• Last updated: January 10, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.

Description:

Phase I, Open-label, Randomized, Single-dose, Two treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Provision of signed, written, and dated informed consent prior to any study specific procedures.

• Healthy male and nonpregnant, nonlactating female 18 to 55 years, inclusive, with suitable veins for cannulation or repeated venipuncture.

• Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg

• Be willing to eat the high-calorie, high-fat breakfast or fast accordingly

• Be able to understand and comply with the requirements of the study as judged by the Investigator

Exclusion Criteria:

• History of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results

• History of gastrointestinal surgery (except for appendectomy) or unintentional rapid weight loss

• History of seizure activity, including febrile seizures

• Past diagnosis of more than 1 episode of major depression

• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TC-5214
Oral tablets, single 4mg dose

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TC-5214 area under the plasma concentration time curve will be measured.		Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose	No
Primary	TC-5214 maximum plasma concentration will be measured		Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose	No
Secondary	The number of participants with adverse events		During day - 1, day 1, 2, 3 and 4 of treatment period	Yes
Secondary	A change from baseline in laboratory assessments		During day - 1 and day 3 of visits 2 and 3 of treatment period	Yes
Secondary	A change from baseline in vital signs		During day - 1, day 1, 2, 3 and 4 of treatment period	Yes
Secondary	A change from baseline in physical examination		During day -1	Yes
Secondary	Description of the pharmacokinetics (PK) of TC-5214 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life		PK samles collected at pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose	No
Secondary	Description of urine pharmacokinetics (PK) of TC-5214 in terms of the cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance		PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose	No