Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport

Completed · Phase 1

Conditions studied: Drug Interaction

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

NCT05334108

Run by

Emalex Biosciences Inc.

People needed

56

Starts

2022-04-26

Expected to finish

2022-08-26

Last updated by the study team

2022-12-12

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
• Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
• 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

• ICON Early Phase Services — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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