Healthy SubjectsPhase 1TC-5214NCT01458899
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214
A Phase 1 study testing TC-5214 in people with Healthy Subjects, run by AstraZeneca at 1 site in United States.
Trial summary
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TC-5214
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
Read the 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
- Conditions
- Healthy Subjects
- Being tested
- TC-5214
- Keywords
- Phase 1, healthy male, nonpregnant female, volunteers, pharmacokinetics, TC 5214, The effect of food on the pharmacokinetics of TC-5214
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-5214Drug
Oral tablets, single 4mg dose
| Study group | Role | What they receive |
|---|---|---|
| A - first fed then fasted treatment | Experimental | TC-5214 Receives: Drug: TC-5214 |
| B - first fasted then fed treatment | Experimental | TC-5214 Receives: Drug: TC-5214 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TC-5214 area under the plasma concentration time curve will be measured.
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
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
Measured: During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in laboratory assessments
Measured: During day - 1 and day 3 of visits 2 and 3 of treatment period
A change from baseline in vital signs
Measured: During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in physical examination
Measured: 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
Measured: 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
Measured: PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans A Eriksson, MD, Study chair, AstraZeneca Kvambergagatan 12, 15185, Sodertalje, SwedenDavid Mathews, MD, Principal investigator, Quintiles, Inc. Overland Park USBrendan Smyth, MD, Study director, AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458899
- Sponsor's protocol ID
- D4130C00025
- Acronym
- TC-5214
- Status last verified
- Jan 2012
- First submitted
- 17 Oct 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01458899
- Acronym / sponsor ID
- TC-5214 / D4130C00025
- Conditions
- Healthy Subjects
- Keywords
- Phase 1, healthy male, nonpregnant female, volunteers, pharmacokinetics, TC 5214, The effect of food on the pharmacokinetics of TC-5214
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - first fed then fasted treatment | Experimental | Drug: TC-5214TC-5214 |
| B - first fasted then fed treatment | Experimental | Drug: TC-5214TC-5214 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-5214Oral tablets, single 4mg dose | Drug | A - first fed then fasted treatment, B - first fasted then fed treatment |
Primary outcome
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
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
6 secondary outcomes
The number of participants with adverse events
Time frame: 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
A change from baseline in vital signs
Time frame: During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in physical examination
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans A Eriksson, MD study chair
AstraZeneca Kvambergagatan 12, 15185, Sodertalje, Sweden
David Mathews, MD principal investigator
Quintiles, Inc. Overland Park US
Brendan Smyth, MD study director
AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TC-5214 in people with Healthy Subjects, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.