Status:
COMPLETED
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
Lead Sponsor:
Emalex Biosciences Inc.
Collaborating Sponsors:
Syneos Health
Nuventra, Inc.
Conditions:
Drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.
Detailed Description
Following a 28-day Screening period, eligible subjects will enter the clinical research unit (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a single dose o...
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
- 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
- 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
- Not suitable for study in the opinion of the Principal Investigator
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04902105
Start Date
May 13 2021
End Date
July 6 2021
Last Update
July 22 2021
Active Locations (1)
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1
Syneos Health Clinical Research Services, LLC.
Miami, Florida, United States, 33136