Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
Stopped early · Phase 1
Conditions studied: Drug-Interactions
In brief
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Key facts
- Study ID
- NCT04764851
- Run by
- Emalex Biosciences Inc.
- People needed
- 30
- Starts
- 2021-02-18
- Expected to finish
- 2021-05-07
- Last updated by the study team
- 2021-05-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male subjects or female subjects of non-childbearing potential
- ≥18 and <55 years of age at the time of consent
- BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
- Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
You may not qualify if…
- Personal or family History of significant medical illness
- Clinically significant abnormalities on screening tests/exams
- History of or significant risk of committing suicide
- Donation of plasma within 7 days prior to dosing
- Donation or significant loss of blood within 30 days prior to the first dosing
- Major surgery within 3 months or minor surgery within 1 month prior to admission
- Use of prohibited prescription, over-the-counter medications or natural health products
- Alcohol-based products 24 hours prior to admission
- Female subjects who are currently pregnant or lactating
- Positive pregnancy test
- Use of tobacco or nicotine products within 3 months prior to Screening
- Significant alcohol consumption
- History of drug abuse within the previous 2 years, or a positive drug screen
- History of allergy to study medications
- Undergoing abrupt discontinuation of alcohol or sedatives
- Not suitable for study in the opinion of the Principal Investigator
Where it is running
- Syneos Health Clinical Research Services, LLC. — Miami, Florida, United States
Full record on ClinicalTrials.gov
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