Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steady State PK Group | Experimental |
| |
| No steady state PK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon | Drug | 20mg daily dosing, Days 4-20 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CYP3A4 Pharmacokinetics | Composite of 24 hour pharmacokinetic parameters of midazolam will be compared between Day 1 and Day 18. | Days 1 and 18 |
| CYP2C8 Pharmacokinetics | Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and 20. | Days 3 and 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam PK | Composite pharmacokinetic parameters of midazolam and α-hydroxymidazolam will be compared between Day 1 and Day 18. | Days 1 and 17 |
| Rosiglitazone PK | Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and Day 20. |
Not provided
Inclusion Criteria:
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;
a. 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:
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;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications | Springfield | Missouri | 65802 | United States |
Not provided
| ID | Term |
|---|---|
| C478745 | tasimelteon |
| D000077154 | Rosiglitazone |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rosiglitazone |
| Drug |
4mg, single dose, Days 3 and 20 |
|
|
| Midazolam | Drug | 10mg, single dose, Days 1 and 18 |
|
| 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). | 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. | Days 1-21 |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |