A Phase 1 interventional study of tasimelteon and tasimelteon in Healthy, sponsored by Vanda Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-17.
Sponsored by Vanda Pharmaceuticals · Phase 1, Interventional, and Basic science
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown product) in the blood when taken alone and in combination with either rifampin or ketoconazole.
Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain medications. In this study, the effect that this important enzyme has on tasimelteon is being studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how they are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme.
In addition, the safety and tolerability of tasimelteon will also be assessed throughout the study.
Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Vital signs which are within the ranges shown below:
Exclusion Criteria:
History of porphyria or liver disease and/or positive for one or more of the following serological results:
Drug: tasimelteon · Drug: Rifampin
Drug: tasimelteon · Drug: Ketoconazole
20mg, oral capsule, once, Days 1 and 12
Also known as: VEC-162, BMS-214778
20mg, oral capsule, once, Days 1 and 6
Also known as: VEC-162, BMS-214778
600mg, oral capsules (2 x 300mg), once daily (QD), Days 2-11
400mg, oral tablets (2 x 200mg), once daily (QD), Days 2-6
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tasimelteon and tasimelteon's metabolites with and without the CYP3A4 inhibitor ketoconazole.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose. Days 6 and 7: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tasimelteon and tasimelteon's metabolites with and without the CYP3A4 inducer rifampin.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose. Days 12 and 13: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours post-dose
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Vanda Pharmaceuticals