Status:
TERMINATED
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
Lead Sponsor:
Emalex Biosciences Inc.
Collaborating Sponsors:
Syneos Health
Nuventra, Inc.
Conditions:
Drug-Interactions
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 of up to 28 days, subjects will be admitted to the clinical research unit into one of three cohorts. On the morning of Day 1, subjects in cohorts 1, 2, and 3 will receive ...
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
- 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 :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04764851
Start Date
February 18 2021
End Date
May 7 2021
Last Update
May 24 2021
Active Locations (1)
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1
Syneos Health Clinical Research Services, LLC.
Miami, Florida, United States, 33136