Clinical trial NCT01458899: Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Phase 1
healthy male
nonpregnant female
volunteers
pharmacokinetics
TC 5214
The effect of food on the pharmacokinetics of TC-5214
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: TC-5214 area under the plasma concentration time curve will be measured.
timeFrame: 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
measure: TC-5214 maximum plasma concentration will be measured
timeFrame: 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
Secondary outcomes:
measure: The number of participants with adverse events
timeFrame: During day - 1, day 1, 2, 3 and 4 of treatment period
measure: A change from baseline in laboratory assessments
timeFrame: During day - 1 and day 3 of visits 2 and 3 of treatment period
measure: A change from baseline in vital signs
timeFrame: During day - 1, day 1, 2, 3 and 4 of treatment period
measure: A change from baseline in physical examination
timeFrame: During day -1
measure: 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
timeFrame: 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
measure: 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
timeFrame: PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca Kvambergagatan 12, 15185, Sodertalje, Sweden
name: Hans A Eriksson, MD
role: STUDY_CHAIR
affiliation: Quintiles, Inc. Overland Park US
name: David Mathews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437
name: Brendan Smyth, MD
role: STUDY_DIRECTOR
References: