Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Absolute Bioavailability of Tasimelteon (Hetlioz) in Healthy Subjects
NCT02130999Phase 4
Key facts
- Status
- Completed
- Start
- May 2014
- Primary completion
- May 2014
- Sponsor
- Vanda Pharmaceuticals Inc.
- Modality
- Small Molecules
- Drugs
- tasimelteon
- Conditions
- Non-24-hour sleep-wake disorder (N24SWD)
01
Overview
Phase 4, randomised, open-label trial of tasimelteon in Non-24-hour sleep-wake disorder (N24SWD) (2 arms), sponsored by Vanda Pharmaceuticals Inc. Primary endpoint: Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mg. Started May 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Sequence A
Oral Tasimelteon 20mg (Day 1) -> Washout -> IV Tasimelteon 2mg (Day 6)
Sequence B
IV Tasimelteon 2mg (Day 1) -> Washout -> Oral Tasimelteon 20mg (Day 6)
03
Who it enrols
Healthy men and women aged 18-55 with BMI 18-25 kg/m2. Non-smokers. Excludes history of drug/alcohol abuse, major surgery within 3 months, significant illness, or use of melatonin/supplements.
04
Endpoints
Primary
Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mg
Secondary
Cmax of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration
AUC (Inf) of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration
T1/2 of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration
Total Clearance of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration
Cmax of Tasimelteon's Metabolites After an Oral and I.V. Dose of Tasimelteon
AUC(Inf) of Tasimelteon's Metabolites After a Single Oral and I.V. Dose
Number of Participants With Adverse Events
Beyond the preview
Go deeper on NCT02130999.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02130999.