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

NCT01458899 | Completed Phase 1

• 1 other identifier: D4130C00025
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

Phase 1; healthy male; nonpregnant female; volunteers; pharmacokinetics; TC 5214; The effect of food on the pharmacokinetics of TC-5214

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• The number of participants with adverse events

  During day - 1, day 1, 2, 3 and 4 of treatment period

• A change from baseline in laboratory assessments

  During day - 1 and day 3 of visits 2 and 3 of treatment period

• A change from baseline in vital signs

  During day - 1, day 1, 2, 3 and 4 of treatment period

• A change from baseline in physical examination

  During day -1

• 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

Study Arms (2)

A - first fed then fasted treatment

EXPERIMENTAL

TC-5214

Drug: TC-5214

B - first fasted then fed treatment

EXPERIMENTAL

TC-5214

Drug: TC-5214

Interventions

TC-5214 DRUG

Oral tablets, single 4mg dose

A - first fed then fasted treatment; B - first fasted then fed treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Study Officials

• Hans A Eriksson, MD

  AstraZeneca Kvambergagatan 12, 15185, Sodertalje, Sweden

  STUDY CHAIR

• David Mathews, MD

  Quintiles, Inc. Overland Park US

  PRINCIPAL INVESTIGATOR

• Brendan Smyth, MD

  AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 25, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)