Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With EthanolPhase 1NCT01578057
Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
A Phase 1 study testing tasimelteon and Ethanol in people with Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol, run by Vanda Pharmaceuticals at 1 site in Canada.
Trial summary
The purpose of this research study is to understand if there is any difference in the effects of tasimelteon when it is taken alone or in combination with alcohol. This research study is also being done to understand if there is any difference in the amount of tasimelteon (and its breakdown products) or alcohol in the… Read more about this study
- Who is it for?
- Ages 19 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol
- What is being tested?
- tasimelteon and Ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Jun 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 19 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and acceptance to provide written informed consent;
- Men or women between 19- 75 years, inclusive;
- Subjects with Body Mass Index (BMI) of ≥18.0 and ≤35.0 kg/m2 (BMI = weight (kg)/ [height (m)]2) and weigh a minimum of 50 kg (110 pounds);
- 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: 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.
- Social or moderate drinkers who drink on average 7 to 21 units of alcohol per week and have consumed more than 4 (women) or 5 (men) units of alcohol on at least one occasion in the last month; Note: One unit of alcohol is equivalent to 1.5 oz of hard liquor or 5 oz of wine or 12 oz of beer.
- Willing and able to comply with study requirements and restrictions;
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- Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis;
- Vital signs (after 3 minutes resting in a semi-supine or seated position) which are within the ranges shown below:
- Body temperature between 35.0-37.5 °C;
- Systolic blood pressure between 90-150 mm Hg;
- Diastolic blood pressure between 50-95 mm Hg;
- Pulse rate between 40-100 bpm.
Who cannot join
- Subjects who are not able to tolerate [0.6 g/kg for female/0.7 g/kg for men] ethanol during the Qualification visit. Intolerance is defined as ≥ 1 vomiting episode or severe nausea.
- Current (within 12 months) drug or alcohol abuse or dependence 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 pulmonary, cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- Subjects who are currently considered a suicide risk, any subject who has ever made a suicide attempt, or those who are currently demonstrating active (within the last year) suicidal ideation as deemed by the Columbia Suicide Severity Rating Scale (C-SSRS);
- Any condition requiring the regular use of medication;
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- Subjects who have used tobacco products 3 months prior to Baseline. Smokers will be defined as any subject who reports cigarette, tobacco, nicotine gum, or nicotine patch use;
- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of Baseline;
- 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 intolerance or 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 B surface antigen (HBsAg)
- A positive hepatitis C antibody test (anti-HCV)
- A positive HIV test result;
- Use of prescription or OTC medication, including melatonin and herbal products (e.g., St. John's Wort) within 2 weeks of the Baseline Visit;
- Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 day preceding the Screening visit;
- Participation in a previous BMS-214778/VEC-162 trial;
- Inability to be venipunctured and/or tolerate venous access;
- Subjects who are unable to read or speak English;
- Any other sound medical reason as determined by the clinical Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-mask, Four-period Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
The purpose of this research study is to understand if there is any difference in the effects of tasimelteon when it is taken alone or in combination with alcohol. This research study is also being done to understand if there is any difference in the amount of tasimelteon (and its breakdown products) or alcohol in the blood when taken alone or together. Finally, the study will also look at the safety and tolerability (how acceptable it is) of tasimelteon.
Read the detailed description
Alcohol is a drug that gets absorbed into the bloodstream quickly. The blood carries the alcohol to the brain where it slows down the messages in the brain (alcohol is a depressant). Alcohol affects a person's memory, behaviour, concentration, alertness (your thought process is slower), and coordination (your movements become clumsy). The intended effect of tasimelteon is to cause sleepiness. Sleepiness may result in similar effects on memory, concentration, alertness, and coordination as alcohol. There is the possibility taking tasimelteon and alcohol together can make these effects stronger or worse.
- Being tested
- tasimelteon, Ethanol, Placebo tasimelteon, Placebo ethanol
- Keywords
- alcohol
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, once
EthanolDrug
Also called vodka
0.6 g/kg ethanol (women) or 0.7 g/kg ethanol (men) in a total volume of 300 mL as a light cranberry juice cocktail, (consumed within 15 minutes).
Placebo tasimelteonOther
once
Placebo ethanolDrug
A total volume of 300 mL as a light cranberry cocktail (consumed within 15 minutes) with about 1 mL of supernatant of ethanol in the top
| Study group | Role | What they receive |
|---|---|---|
| tasimelteon + placebo ethanol | Experimental | Not described Receives: Drug: tasimelteon; Drug: Placebo ethanol |
| ethanol + placebo tasimelteon | Experimental | Not described Receives: Drug: Ethanol; Other: Placebo tasimelteon |
| tasimelteon + ethanol | Experimental | Not described Receives: Drug: tasimelteon; Drug: Ethanol |
| placebo tasimelteon + placebo ethanol | Experimental | Not described Receives: Other: Placebo tasimelteon; Drug: Placebo ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic parameters (Digit Vigilance, Digit Symbol Substitution Task, Hopkins Verbal Learning Test Revised , Divided Attention Test, Balance Platform Test, Choice Reaction Time, Visual Analog Scale) as measured by peak change from baseline
Differences will be calculated for the following comparisons:
- Ethanol Alone vs. Placebo-Placebo
- Ethanol Alone vs. Tasimelteon + Ethanol
- Tasimelteon Alone vs. Placebo-Placebo
- Tasimelteon Alone vs. Tasimelteon + Ethanol
Measured: Days 1, 8, 15, 22: at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after dose
Secondary outcomes (3)
Pharmacokinetic parameters (AUC, Cmax, Tmax) of tasimelteon, tasimelteon's metabolites, and ethanol
Measured: Approximately Days 1, 8, 15, and 22: predose, 0.25, 0.75, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after dosing
Safety and tolerability as measured by spontaneous reporting of AEs, and clinically significant changes in laboratory parameters, ECG parameters, and vital signs
Measured: Screening (approximately Day -10), Days -2, -1, 1, and approximately Days 8, 15, 22, 23
The Columbia-Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation.
Measured: once per day at Screening (approximately day -7),Day -1 (baseline), approximately Days 1, 8, 15, 22 and 23 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With EthanolStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578057
- Sponsor's protocol ID
- VP-VEC-162-1108
- Status last verified
- Feb 2014
- First submitted
- 12 Apr 2012
- 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
- A Randomized, Double-mask, Four-period Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
- ClinicalTrials.gov ID
- NCT01578057
- Acronym / sponsor ID
- VP-VEC-162-1108
- Keywords
- alcohol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Apr 2012 (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 if there is any difference in the effects of tasimelteon when it is taken alone or in combination with alcohol. This research study is also being done to understand if there is any difference in the amount of tasimelteon (and its breakdown products) or alcohol in the blood when taken alone or together. Finally, the study will also look at the safety and tolerability (how acceptable it is) of tasimelteon.
Detailed description
Alcohol is a drug that gets absorbed into the bloodstream quickly. The blood carries the alcohol to the brain where it slows down the messages in the brain (alcohol is a depressant). Alcohol affects a person's memory, behaviour, concentration, alertness (your thought process is slower), and coordination (your movements become clumsy). The intended effect of tasimelteon is to cause sleepiness. Sleepiness may result in similar effects on memory, concentration, alertness, and coordination as alcohol. There is the possibility taking tasimelteon and alcohol together can make these effects stronger or worse.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tasimelteon + placebo ethanol | Experimental | Drug: tasimelteon, Drug: Placebo ethanol |
| ethanol + placebo tasimelteon | Experimental | Drug: Ethanol, Other: Placebo tasimelteon |
| tasimelteon + ethanol | Experimental | Drug: tasimelteon, Drug: Ethanol |
| placebo tasimelteon + placebo ethanol | Experimental | Other: Placebo tasimelteon, Drug: Placebo ethanol |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability and acceptance to provide written informed consent;
- Men or women between 19- 75 years, inclusive;
- Subjects with Body Mass Index (BMI) of ≥18.0 and ≤35.0 kg/m2 (BMI = weight (kg)/ [height (m)]2) and weigh a minimum of 50 kg (110 pounds);
- 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: 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.
- Social or moderate drinkers who drink on average 7 to 21 units of alcohol per week and have consumed more than 4 (women) or 5 (men) units of alcohol on at least one occasion in the last month; Note: One unit of alcohol is equivalent to 1.5 oz of hard liquor or 5 oz of wine or 12 oz of beer.
Key exclusion criteria (22 listed)
- Subjects who are not able to tolerate [0.6 g/kg for female/0.7 g/kg for men] ethanol during the Qualification visit. Intolerance is defined as ≥ 1 vomiting episode or severe nausea.
- Current (within 12 months) drug or alcohol abuse or dependence 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 pulmonary, cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- Subjects who are currently considered a suicide risk, any subject who has ever made a suicide attempt, or those who are currently demonstrating active (within the last year) suicidal ideation as deemed by the Columbia Suicide Severity Rating Scale (C-SSRS);
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, once | Drug | tasimelteon + ethanol, tasimelteon + placebo ethanol |
| EthanolAlso: vodka0.6 g/kg ethanol (women) or 0.7 g/kg ethanol (men) in a total volume of 300 mL as a light cranberry juice cocktail, (consumed within 15 minutes). | Drug | ethanol + placebo tasimelteon, tasimelteon + ethanol |
| Placebo tasimelteononce | Other | ethanol + placebo tasimelteon, placebo tasimelteon + placebo ethanol |
| Placebo ethanolA total volume of 300 mL as a light cranberry cocktail (consumed within 15 minutes) with about 1 mL of supernatant of ethanol in the top | Drug | placebo tasimelteon + placebo ethanol, tasimelteon + placebo ethanol |
Primary outcome
Pharmacodynamic parameters (Digit Vigilance, Digit Symbol Substitution Task, Hopkins Verbal Learning Test Revised , Divided Attention Test, Balance Platform Test, Choice Reaction Time, Visual Analog Scale) as measured by peak change from baseline
Time frame: Days 1, 8, 15, 22: at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after dose
Differences will be calculated for the following comparisons: * Ethanol Alone vs. Placebo-Placebo * Ethanol Alone vs. Tasimelteon + Ethanol * Tasimelteon Alone vs. Placebo-Placebo * Tasimelteon Alone vs. Tasimelteon + Ethanol
3 secondary outcomes
Pharmacokinetic parameters (AUC, Cmax, Tmax) of tasimelteon, tasimelteon's metabolites, and ethanol
Time frame: Approximately Days 1, 8, 15, and 22: predose, 0.25, 0.75, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after dosing
Safety and tolerability as measured by spontaneous reporting of AEs, and clinically significant changes in laboratory parameters, ECG parameters, and vital signs
Time frame: Screening (approximately Day -10), Days -2, -1, 1, and approximately Days 8, 15, 22, 23
The Columbia-Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation.
Time frame: once per day at Screening (approximately day -7),Day -1 (baseline), approximately Days 1, 8, 15, 22 and 23 (end of study)
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.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Ethanol in people with Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol, run by Vanda Pharmaceuticals at 1 site in Canada.
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 12 inclusion and 22 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 Canada. 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?
Pharmacodynamic parameters (Digit Vigilance, Digit Symbol Substitution Task, Hopkins Verbal Learning Test Revised , Divided Attention Test, Balance Platform Test, Choice Reaction Time, Visual Analog Scale) as measured by peak change from baseline (time frame: Days 1, 8, 15, 22: at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after dose). 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.