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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: TC-5214

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458899
D4130C00025

Details and patient eligibility

About

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

Full 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

Enrollment

18 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

A - first fed then fasted treatment
Experimental group
Description:
TC-5214
Treatment:
Drug: TC-5214
B - first fasted then fed treatment
Experimental group
Description:
TC-5214
Treatment:
Drug: TC-5214

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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