- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458899
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214 (TC-5214)
January 10, 2012 updated by: AstraZeneca
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
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A - first fed then fasted treatment
TC-5214
|
Oral tablets, single 4mg dose
|
Experimental: B - first fasted then fed treatment
TC-5214
|
Oral tablets, single 4mg dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TC-5214 area under the plasma concentration time curve will be measured.
Time Frame: 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
|
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
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of participants with adverse events
Time Frame: During day - 1, day 1, 2, 3 and 4 of treatment period
|
During day - 1, day 1, 2, 3 and 4 of treatment period
|
A change from baseline in laboratory assessments
Time Frame: During day - 1 and day 3 of visits 2 and 3 of treatment period
|
During day - 1 and day 3 of visits 2 and 3 of treatment period
|
A change from baseline in vital signs
Time Frame: During day - 1, day 1, 2, 3 and 4 of treatment period
|
During day - 1, day 1, 2, 3 and 4 of treatment period
|
A change from baseline in physical examination
Time Frame: During day -1
|
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
Time Frame: 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
|
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
|
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
Time Frame: PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose
|
PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hans A Eriksson, MD, AstraZeneca Kvambergagatan 12, 15185, Sodertalje, Sweden
- Principal Investigator: David Mathews, MD, Quintiles, Inc. Overland Park US
- Study Director: Brendan Smyth, MD, AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 17, 2011
First Submitted That Met QC Criteria
October 24, 2011
First Posted (Estimate)
October 25, 2011
Study Record Updates
Last Update Posted (Estimate)
January 11, 2012
Last Update Submitted That Met QC Criteria
January 10, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D4130C00025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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