Status:
COMPLETED
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport
Lead Sponsor:
Emalex Biosciences Inc.
Collaborating Sponsors:
ICON Early Phase Services
Nuventra, Inc.
Conditions:
Drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Detailed Description
Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam tw...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05334108
Start Date
April 26 2022
End Date
August 26 2022
Last Update
December 12 2022
Active Locations (1)
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1
ICON Early Phase Services
San Antonio, Texas, United States, 78209