Healthy VolunteersPhase 1NCT01477619
Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects
A Phase 1 study testing Tasimelteon in people with Healthy Volunteers, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the pharmacokinetics of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tasimelteon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Groups 1 and 2:
- Men or women between 18 - 55 years, inclusive;
- Smokers who test positive for cotinine at screening and baseline and smoke at least 10 cigarettes per day, for at least 6 months prior to screening (Group 1) OR Non-smokers [abstinence from smoking for at least 6 months before the screening visit and test negative for cotinine at screening and baseline (Group 2)] who are matched to Group 1 by gender, age (±10 years), and BMI category [underweight/normal (≤ 24.99), overweight (25.00-29.99), and obese (≥ 30.00)];
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and females must have a negative pregnancy test at the screening and baseline visits; Note 1: Acceptable methods of birth control include any one of the following: abstinence, vasectomized sexual partner, hormonal methods (i.e. pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical cap, or condom with spermicidal jelly or foam.
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
- Body temperature between 35.0-37.5 °C;
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- Systolic blood pressure between 90-150 mmHg;
- Diastolic blood pressure between 50-95 mmHg;
- Pulse rate between 50-100 bpm.
- Group 3:
- Men or women 65 years of age or older;
- Non-smokers (abstinence from smoking for at least 6 months before the start of the study and test negative for cotinine at screening and baseline);
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
- Systolic blood pressure between 90-160 mmHg;
- Diastolic blood pressure between 50-99 mmHg;
- Pulse rate between 50-100 bpm.
- Groups 1-3:
- Ability and acceptance to provide written informed consent;
- Willing and able to comply with study requirements and restrictions;
- Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis;
Who cannot join
- History of recent (within six months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse or evidence of such abuse as indicated by the laboratory assays conducted during the Screening Visit or at Baseline;
- Any major surgery within three months of Baseline or any minor surgery within one month;
- History or current evidence of cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- Any condition requiring the regular use of medication except those listed in Section 8.2;
- Use of any melatonin preparation chronically within 2 months prior to Day 1 or any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) within 60 days prior to Day 1.
- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of baseline;
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- Donation or loss of 400 mL or more of blood within two months prior to the Baseline Visit;
- Significant illness within the two weeks prior to Baseline;
- A known hypersensitivity to tasimelteon or drugs similar to tasimelteon including melatonin;
- Pregnant or lactating females;
- History of liver disease and/or positive for one or more of the following serological results:
- A positive hepatitis C antibody test (anti-HCV)
- A positive hepatitis B surface antigen (HBsAg)
- A positive HIV test result
- Any surgical or medical condition which might significantly alter the absorption, distribution or excretion of any drug. The Investigator should be guided by evidence of any of the following:
- Clinically significant gastritis, ulcers, gastrointestinal or rectal bleeding within 5 years of the screening visit;
- History of inflammatory bowel syndrome, major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- Pancreatic injury or pancreatitis within 5 years of the screening visit;
- Clinically significant urinary obstruction or difficulty voiding within 3 years of the screening visit;
- Exposure (within 2 weeks of the Baseline Visit) of any over-the-counter medications including dietary supplements and/or herbal remedies, except those listed in Section 8.2;
- Use of any food or beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g. kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard greens) and charbroiled meats for at least 2 weeks before the Baseline Visit until the end of the study;
- Inability to be venipunctured and/or tolerate venous access;
- Subjects who are unable to read or speak English;
- Participation in a previous BMS-214778/VEC-162 trial;
- Any other sound medical reason as determined by the clinical Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications
Springfield, Missouri
About this study
Official title: An Open-label, Single Dose, Parallel Group Study to Assess the Effects of Smoking Status, Age and Body Size on the Pharmacokinetics, Safety, and Tolerability of Tasimelteon in Healthy Volunteers
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the pharmacokinetics of tasimelteon.
- Conditions
- Healthy Volunteers
- Being tested
- Tasimelteon
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasimelteonDrug
Also called VEC-162, BMS-214778
20mg single dose on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Split into BMI categories Receives: Drug: Tasimelteon |
| Non-Smokers | Experimental | Gender, age, and BMI matched to Smokers Receives: Drug: Tasimelteon |
| Elderly | Experimental | Not described Receives: Drug: Tasimelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tasimelteon plasma concentrations and pharmacokinetics in smokers versus non-smokers
Plasma concentrations and pharmacokinetics of tasimelteon of group 1 (smokers) will be compared to group 2 (non-smokers)
Measured: Day 1 - Day 2
To assess the effect of weight, body mass index (BMI), and age on the pharmacokinetic profile of tasimelteon
Pharmacokinetics of tasimelteon will be compared using all three groups (smokers, non-smokers and elderly). Group 1 and Group 2 will be gender, age and BMI category matched.
Measured: Day 1 -Day 2
Secondary outcomes (3)
To assess plasma concentrations and pharmacokinetics of tasimelteon metabolites (M3, M9, M11, M12, M13, and M14) in subjects who smoke compared to subjects who do not smoke.
Composite of 24 hour pharmacokinetic parameters will be compared between group 1 (smokers) and group 2 (non-smokers)
Measured: Day 1 - Day 2
To assess the effect of weight, BMI, and age on the pharmacokinetic profile of tasimelteon metabolites (M3, M9, M11, M12, M13, and M14).
Composite of 24 hour pharmacokinetic parameters will be compared using all three groups (smokers, non-smokers and elderly). Group 1 and Group 2 will be gender, age and BMI category matched.
Measured: Day 1 - Day 2
Tasimelteon safety and tolerability
Safety of single dose as measured by adverse event reporting.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 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 VolunteersStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals, Study director, Vanda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477619
- Sponsor's protocol ID
- VP-VEC-162-1107
- Status last verified
- Feb 2014
- First submitted
- 17 Nov 2011
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose, Parallel Group Study to Assess the Effects of Smoking Status, Age and Body Size on the Pharmacokinetics, Safety, and Tolerability of Tasimelteon in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01477619
- Acronym / sponsor ID
- VP-VEC-162-1107
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Nov 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.
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the pharmacokinetics of tasimelteon.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Drug: TasimelteonSplit into BMI categories |
| Non-Smokers | Experimental | Drug: TasimelteonGender, age, and BMI matched to Smokers |
| Elderly | Experimental | Drug: Tasimelteon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Men or women between 18 - 55 years, inclusive;
- Smokers who test positive for cotinine at screening and baseline and smoke at least 10 cigarettes per day, for at least 6 months prior to screening (Group 1) OR Non-smokers [abstinence from smoking for at least 6 months before the screening visit and test negative for cotinine at screening and baseline (Group 2)] who are matched to Group 1 by gender, age (±10 years), and BMI category [underweight/normal (≤ 24.99), overweight (25.00-29.99), and obese (≥ 30.00)];
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and females must have a negative pregnancy test at the screening and baseline visits; Note 1: Acceptable methods of birth control include any one of the following: abstinence, vasectomized sexual partner, hormonal methods (i.e. pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical cap, or condom with spermicidal jelly or foam.
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
- Men or women 65 years of age or older;
Key exclusion criteria (25 listed)
- History of recent (within six months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse or evidence of such abuse as indicated by the laboratory assays conducted during the Screening Visit or at Baseline;
- Any major surgery within three months of Baseline or any minor surgery within one month;
- History or current evidence of cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- Any condition requiring the regular use of medication except those listed in Section 8.2;
- Use of any melatonin preparation chronically within 2 months prior to Day 1 or any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) within 60 days prior to Day 1.
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 |
|---|---|---|
| TasimelteonAlso: VEC-162, BMS-21477820mg single dose on Day 1 | Drug | Elderly, Non-Smokers, Smokers |
Primary outcome
Tasimelteon plasma concentrations and pharmacokinetics in smokers versus non-smokers
Time frame: Day 1 - Day 2
Plasma concentrations and pharmacokinetics of tasimelteon of group 1 (smokers) will be compared to group 2 (non-smokers)
To assess the effect of weight, body mass index (BMI), and age on the pharmacokinetic profile of tasimelteon
Time frame: Day 1 -Day 2
Pharmacokinetics of tasimelteon will be compared using all three groups (smokers, non-smokers and elderly). Group 1 and Group 2 will be gender, age and BMI category matched.
3 secondary outcomes
To assess plasma concentrations and pharmacokinetics of tasimelteon metabolites (M3, M9, M11, M12, M13, and M14) in subjects who smoke compared to subjects who do not smoke.
Time frame: Day 1 - Day 2
To assess the effect of weight, BMI, and age on the pharmacokinetic profile of tasimelteon metabolites (M3, M9, M11, M12, M13, and M14).
Time frame: Day 1 - Day 2
Tasimelteon safety and tolerability
Time frame: Day 1
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 17 Feb 2014.
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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.
Vanda Pharmaceuticals study director
Vanda Pharmaceuticals
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 Tasimelteon in people with Healthy Volunteers, run by Vanda Pharmaceuticals 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 20 inclusion and 25 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 17 Feb 2014. 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?
Tasimelteon plasma concentrations and pharmacokinetics in smokers versus non-smokers (time frame: Day 1 - Day 2). 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 17 Feb 2014.