Healthy VolunteersPhase 1NCT01540500
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
A Phase 1 study testing Tasimelteon and Fluvoxamine 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 evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tasimelteon and Fluvoxamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 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
- Men or women between 18 - 55 years, inclusive;
- Non-smokers [abstinence from smoking for at least 6 months before the screening visit] and test negative for cotinine at screening and baseline;
- Subjects with Body Mass Index (BMI) of ≥18 and ≤35 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- 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:
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- Body temperature between 35.0-37.5 °C;
- Systolic blood pressure between 90-150 mmHg;
- Diastolic blood pressure between 50-95 mmHg;
- Pulse rate between 50-100 bpm.
- 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.
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;
- 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 except those listed on Section 8.2;
- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of baseline;
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- Anyone who has taken a melatonin preparation chronically within the past two months prior to Day 1;
- 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 fluvoxamine, tasimelteon or drugs similar to tasimelteon (including melatonin) or fluvoxamine;
- 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
- Exposure (within 2 weeks of the Baseline Visit) of any over-the-counter medications including dietary supplements and/or herbal remedies, except those listed on Section 8.2;
- Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 days preceding the Screening visit;
- Participation in a previous BMS-214778/VEC-162 trial;
- 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;
- 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, 65802
About this study
Official title: An Open-label, Single-sequence Study in Healthy Subjects to Evaluate the Single-dose Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP1A2 Inhibitor, Fluvoxamine
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- Tasimelteon, Fluvoxamine
- Keywords
- Pharmacokinetics, Drug Interaction
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
5.66 mg dose on Day 1 and Day 8
FluvoxamineDrug
50 mg Dose on Days 2-8
| Study group | Role | What they receive |
|---|---|---|
| Steady State PK Group | Experimental | Not described Receives: Drug: Tasimelteon; Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax)
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12 and 24 hours post-dose.
Secondary outcomes (4)
Safety and tolerability as measured by spontaneous reporting of AEs, and clinically significant changes in laboratory parameters, ECG parameters, and vital signs
Measured: Days 1-9
The Columbia Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation.
Measured: Screening, Day -1 (baseline), and Day 9 (end of study)
Pharmacokinetic parameters (AUC, Cmax, Tmax) of tasimelteon metabolites M9, M11, M12, M13, and M14
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12 and 24 hours post-dose.
Fluvoxamine pharmacokinetic parameters (AUC, Cmax, Tmax)
Measured: Pre-dose, 1, 3, 4, 6, 8, 12, and 24 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 posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionMar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01540500
- Sponsor's protocol ID
- VP-VEC-162-1111
- Status last verified
- Feb 2014
- First submitted
- 22 Feb 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
- An Open-label, Single-sequence Study in Healthy Subjects to Evaluate the Single-dose Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP1A2 Inhibitor, Fluvoxamine
- ClinicalTrials.gov ID
- NCT01540500
- Acronym / sponsor ID
- VP-VEC-162-1111
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Feb 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 evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steady State PK Group | Experimental | Drug: Tasimelteon, Drug: Fluvoxamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Men or women between 18 - 55 years, inclusive;
- Non-smokers [abstinence from smoking for at least 6 months before the screening visit] and test negative for cotinine at screening and baseline;
- Subjects with Body Mass Index (BMI) of ≥18 and ≤35 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- 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.
Key exclusion criteria (22 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;
- 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 except those listed on Section 8.2;
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-2147785.66 mg dose on Day 1 and Day 8 | Drug | Steady State PK Group |
| Fluvoxamine50 mg Dose on Days 2-8 | Drug | Steady State PK Group |
Primary outcome
Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12 and 24 hours post-dose.
4 secondary outcomes
Safety and tolerability as measured by spontaneous reporting of AEs, and clinically significant changes in laboratory parameters, ECG parameters, and vital signs
Time frame: Days 1-9
The Columbia Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation.
Time frame: Screening, Day -1 (baseline), and Day 9 (end of study)
Pharmacokinetic parameters (AUC, Cmax, Tmax) of tasimelteon metabolites M9, M11, M12, M13, and M14
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12 and 24 hours post-dose.
Fluvoxamine pharmacokinetic parameters (AUC, Cmax, Tmax)
Time frame: Pre-dose, 1, 3, 4, 6, 8, 12, and 24 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 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 and Fluvoxamine 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 13 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 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 pharmacokinetic parameters (AUC, Cmax, Tmax) (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12 and 24 hours post-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.