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- Klinische proef NCT01402076
A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Missouri
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Springfield, Missouri, Verenigde Staten, 65802
- Bio-Kinetic Clinical Applications
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
- 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;
Exclusion Criteria:
- 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;
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Steady State PK Group
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20mg daily dosing, Days 4-20
4mg, single dose, Days 3 and 20
Andere namen:
10mg, single dose, Days 1 and 18
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Experimenteel: No steady state PK
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20mg daily dosing, Days 4-20
4mg, single dose, Days 3 and 20
Andere namen:
10mg, single dose, Days 1 and 18
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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CYP3A4 Pharmacokinetics
Tijdsspanne: Days 1 and 18
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Composite of 24 hour pharmacokinetic parameters of midazolam will be compared between Day 1 and Day 18.
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Days 1 and 18
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CYP2C8 Pharmacokinetics
Tijdsspanne: Days 3 and 20
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Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and 20.
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Days 3 and 20
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Midazolam PK
Tijdsspanne: Days 1 and 17
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Composite pharmacokinetic parameters of midazolam and α-hydroxymidazolam will be compared between Day 1 and Day 18.
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Days 1 and 17
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Rosiglitazone PK
Tijdsspanne: Days 3 and 20
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Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and Day 20.
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Days 3 and 20
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Tasimelteon multiple dose pharmacokinetics
Tijdsspanne: Days 4-21
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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).
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Days 4-21
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Tasimelteon safety and tolerability
Tijdsspanne: Days 1-21
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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.
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Days 1-21
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hypoglycemische middelen
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Anesthesie, intraveneus
- Anesthesie, generaal
- Anesthesie
- Rustgevende agenten
- Psychotrope medicijnen
- Hypnotica en sedativa
- Adjuvantia, anesthesie
- Middelen tegen angst
- GABA-modulatoren
- GABA-agenten
- Midazolam
- Rosiglitazon
Andere studie-ID-nummers
- VP-VEC-162-1110
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gezonde vrijwilligers
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University of LeicesterNational Institute for Health Research, United KingdomVoltooidPatiënten met hartfalen en behouden ejectiefractie - HFpEF | Patiënten met hartfalen met verminderde ejectiefractie - HFrEF | Healthy Controls Group - Leeftijd en geslacht afgestemd
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University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesBeëindigdZiekte van Parkinson | Healthy Controls Group - Leeftijd en geslacht afgestemdFrankrijk
Klinische onderzoeken op Tasimelteon
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Vanda PharmaceuticalsWervingSlaapstoornis | Slaap stoornis | Autisme Spectrum Stoornis | Neurologische stoornisVerenigde Staten
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Vanda PharmaceuticalsVoltooid
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Vanda PharmaceuticalsVoltooid
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Brigham and Women's HospitalVanda PharmaceuticalsNog niet aan het wervenREM-gedragsstoornisVerenigde Staten
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Vanda PharmaceuticalsVoltooidSmith-Magenis-syndroom | CircadiaansVerenigde Staten
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Vanda PharmaceuticalsVoltooidJet Lag-stoornisVerenigde Staten
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Vanda PharmaceuticalsWervingEvaluatie van de effecten van Tasimelteon vs. Placebo bij vertraagde slaap-waakfase-stoornis (DSWPD)Slaap-waakstoornissen | Slaapstoornissen, circadiaans ritme | Chronobiologische stoornissenVerenigde Staten, Australië, Duitsland
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Vanda PharmaceuticalsVoltooidJetlag-type slapeloosheidVerenigde Staten
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Vanda PharmaceuticalsVoltooidNiet-24-uurs-slaap-waakstoornis
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Vanda PharmaceuticalsVoltooidNiet-24-uurs slaap-waakstoornisVerenigde Staten, Duitsland