Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol

February 14, 2014 updated by: Vanda Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V 2TC
        • INC Research Toronto, Inc.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Ability and acceptance to provide written informed consent;
  2. Men or women between 19- 75 years, inclusive;
  3. 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);
  4. 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.
  5. 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.
  6. Willing and able to comply with study requirements and restrictions;
  7. Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis;

  8. Vital signs (after 3 minutes resting in a semi-supine or seated position) which are within the ranges shown below:

    1. Body temperature between 35.0-37.5 °C;
    2. Systolic blood pressure between 90-150 mm Hg;
    3. Diastolic blood pressure between 50-95 mm Hg;
    4. Pulse rate between 40-100 bpm.

Exclusion Criteria:

  1. 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.
  2. 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;
  3. Any major surgery within three months of Baseline or any minor surgery within one month;
  4. History or current evidence of pulmonary, cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
  5. 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);
  6. Any condition requiring the regular use of medication;
  7. 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;
  8. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of Baseline;
  9. Donation or loss of 400 mL or more of blood within two months prior to the Baseline Visit;
  10. Significant illness within the two weeks prior to Baseline;
  11. A known intolerance or hypersensitivity to tasimelteon or drugs similar to tasimelteon including melatonin;
  12. Pregnant or lactating females;

  13. History of liver disease and/or positive for one or more of the following serological results:

    1. A positive hepatitis B surface antigen (HBsAg)
    2. A positive hepatitis C antibody test (anti-HCV)
    3. A positive HIV test result;
  14. Use of prescription or OTC medication, including melatonin and herbal products (e.g., St. John's Wort) within 2 weeks of the Baseline Visit;
  15. Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 day preceding the Screening visit;
  16. Participation in a previous BMS-214778/VEC-162 trial;
  17. Inability to be venipunctured and/or tolerate venous access;
  18. Subjects who are unable to read or speak English;
  19. Any other sound medical reason as determined by the clinical Investigator.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: tasimelteon + placebo ethanol
Drug: tasimelteon
20mg, once
Other Names:
  • VEC-162
  • BMS-214778
Drug: Placebo ethanol
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
EXPERIMENTAL: ethanol + placebo tasimelteon
Drug: Ethanol
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).
Other Names:
  • vodka
Other: Placebo tasimelteon
once
EXPERIMENTAL: tasimelteon + ethanol
Drug: tasimelteon
20mg, once
Other Names:
  • VEC-162
  • BMS-214778
Drug: Ethanol
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).
Other Names:
  • vodka
EXPERIMENTAL: placebo tasimelteon + placebo ethanol
Drug: Placebo ethanol
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
Other: Placebo tasimelteon
once

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Days 1, 8, 15, 22: at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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)
once per day at Screening (approximately day -7),Day -1 (baseline), approximately Days 1, 8, 15, 22 and 23 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanda Pharmaceuticals

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VP-VEC-162-1108

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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