Healthy VolunteersPhase 1NCT01402076
A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects
A Phase 1 study testing Tasimelteon, Rosiglitazone and Midazolam 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 midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with… 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, Rosiglitazone and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2011
- 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
- Ability and acceptance to provide written informed consent;
- Subjects must be males or females between 18 and 55 years of age, inclusive;
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum or urine pregnancy test at the Screening visit and at Check-in (Days -1) and agree not to attempt to become pregnant during the course of the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual bleeding within 1 year) must be using appropriate birth control (e.g. intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or abstinence, or cervical cap) for a period of 35 days before the first dosing, for the duration of the study, and for one month after the last dose;
- Note: Women are not permitted to use hormonal methods of birth control (e.g. oral contraceptives, hormonal intrauterine device [IUD], patch and steroids) and must use another acceptable method of birth control during the study and for one month after the last dose. Women currently taking oral contraceptives will be required to discontinue their regimen two weeks prior to first dosing.
- Subjects with Body Mass Index (BMI) of >18 and <35 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- 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 mm Hg;
- Diastolic blood pressure between 50-95 mm Hg;
- Pulse rate between 50-100 bpm.
- Willing and able to comply with study requirements;
- 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;
- Any major surgery within three months of Day 1 or any minor surgery within one month;
- Donation or loss of 400 mL or more of blood within two months prior to the Baseline Visit;
- 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;
- History of intolerance and/or hypersensitivity to drugs including midazolam, rosiglitazone or other 'glitazones', melatonin or melatonin agonists, or anyone who has taken a melatonin preparation chronically within the past two months prior to Day 1;
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- History of or current evidence of hypoglycemia judged by the Investigator to be clinically significant;
- History of liver disease and/or positive for one or more of the following serological results: HCV, HIV, HBsAg
- Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 day preceding Day 1;
- Elevated (> 2 times the upper limit of normal) liver function tests (i.e. aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and total bilirubin);
- Inability to be venipunctured and/or tolerate venous access;
- Subjects who have used tobacco products 3 months prior to dosing.
- Exposure to any investigational drug within 30 days or 5 half lives (whichever is longer) of baseline, including placebo;
- Participation in a previous BMS-214778/VEC-162 trial;
- Use of prescription or OTC medication, including herbal products (e.g., St. John's Wort) within 2 weeks of Day 1;
- Use of any food or beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g. kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard) and charbroiled meats within 1 week before Day 1 and during the actual duration of the study;
- 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 to Assess the Effect of Multiple Doses of Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes Using Midazolam and Rosiglitazone as Substrates in Healthy Subjects
The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.
- Conditions
- Healthy Volunteers
- Being tested
- Tasimelteon, Rosiglitazone, Midazolam
- Keywords
- Pharmacokinetics, Drug Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasimelteonDrug
20mg daily dosing, Days 4-20
RosiglitazoneDrug
Also called Avandia
4mg, single dose, Days 3 and 20
MidazolamDrug
10mg, single dose, Days 1 and 18
| Study group | Role | What they receive |
|---|---|---|
| Steady State PK Group | Experimental | Not described Receives: Drug: Tasimelteon; Drug: Rosiglitazone; Drug: Midazolam |
| No steady state PK | Experimental | Not described Receives: Drug: Tasimelteon; Drug: Rosiglitazone; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP3A4 Pharmacokinetics
Composite of 24 hour pharmacokinetic parameters of midazolam will be compared between Day 1 and Day 18.
Measured: Days 1 and 18
CYP2C8 Pharmacokinetics
Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and 20.
Measured: Days 3 and 20
Secondary outcomes (4)
Midazolam PK
Composite pharmacokinetic parameters of midazolam and α-hydroxymidazolam will be compared between Day 1 and Day 18.
Measured: Days 1 and 17
Rosiglitazone PK
Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and Day 20.
Measured: Days 3 and 20
Tasimelteon multiple dose pharmacokinetics
Composite of 24 hour pharmacokinetic parameters of tasimelteon and tasimelteon metabolites M9, M11, M12, M13, and M14, at Days 5, 8, 11, 14 (Group 1 only), and Days 17 and 19 (Groups 1 and 2).
Measured: Days 4-21
Tasimelteon safety and tolerability
Safety of multiple oral doses of 20 mg of tasimelteon alone and in combination with 10 mg of midazolam as measured by vital signs, ECG, and adverse event reporting.
Measured: Days 1-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- 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
- NCT01402076
- Sponsor's protocol ID
- VP-VEC-162-1110
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 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-Sequence Study to Assess the Effect of Multiple Doses of Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes Using Midazolam and Rosiglitazone as Substrates in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01402076
- Acronym / sponsor ID
- VP-VEC-162-1110
- 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
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Jul 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 midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steady State PK Group | Experimental | Drug: Tasimelteon, Drug: Rosiglitazone, Drug: Midazolam |
| No steady state PK | Experimental | Drug: Tasimelteon, Drug: Rosiglitazone, Drug: Midazolam |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Ability and acceptance to provide written informed consent;
- Subjects must be males or females between 18 and 55 years of age, inclusive;
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum or urine pregnancy test at the Screening visit and at Check-in (Days -1) and agree not to attempt to become pregnant during the course of the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual bleeding within 1 year) must be using appropriate birth control (e.g. intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or abstinence, or cervical cap) for a period of 35 days before the first dosing, for the duration of the study, and for one month after the last dose;
- Subjects with Body Mass Index (BMI) of >18 and <35 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
Key exclusion criteria (17 listed)
- History of recent (within six months) drug or alcohol abuse;
- Any major surgery within three months of Day 1 or any minor surgery within one month;
- Donation or loss of 400 mL or more of blood within two months prior to the Baseline Visit;
- 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;
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 |
|---|---|---|
| Tasimelteon20mg daily dosing, Days 4-20 | Drug | No steady state PK, Steady State PK Group |
| RosiglitazoneAlso: Avandia4mg, single dose, Days 3 and 20 | Drug | No steady state PK, Steady State PK Group |
| Midazolam10mg, single dose, Days 1 and 18 | Drug | No steady state PK, Steady State PK Group |
Primary outcome
CYP3A4 Pharmacokinetics
Time frame: Days 1 and 18
Composite of 24 hour pharmacokinetic parameters of midazolam will be compared between Day 1 and Day 18.
CYP2C8 Pharmacokinetics
Time frame: Days 3 and 20
Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and 20.
4 secondary outcomes
Midazolam PK
Time frame: Days 1 and 17
Rosiglitazone PK
Time frame: Days 3 and 20
Tasimelteon multiple dose pharmacokinetics
Time frame: Days 4-21
Tasimelteon safety and tolerability
Time frame: Days 1-21
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, Rosiglitazone and Midazolam 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 12 inclusion and 17 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?
CYP3A4 Pharmacokinetics (time frame: Days 1 and 18). 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.