Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
NCT ID: NCT04764851
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2021-02-18
2021-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1
ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days
Cohort 1 Probe Cocktail given on 2 separate days:
* midazolam: 1 µg infused IV
* caffeine: 200 mg oral tablet
* omeprazole: two 20 mg oral tablets
* dextromethorphan: 1.6mL (containing \~10 mg) oral solution
ecopipam HCl ~2mg/kg/day
oral tablet
Cohort 1 Probe Cocktail
dextromethorphan, caffeine, omeprazole, and midazolam
Cohort 2
ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days
Cohort 2 Probe Cocktail given on 3 separate days:
* midazolam: 10 µg/mL given as 1mL oral solution.
* dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution
* rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution
ecopipam HCl ~2mg/kg/day
oral tablet
Cohort 2 Probe Cocktail
dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
Cohort 3
ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days
Cohort 3 Probe Cocktail given on 2 separate days:
\- bupropion: 100mg oral tablet
ecopipam HCl ~2mg/kg/day
oral tablet
Cohort 3 Probe Cocktail
bupropion
Interventions
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ecopipam HCl ~2mg/kg/day
oral tablet
Cohort 1 Probe Cocktail
dextromethorphan, caffeine, omeprazole, and midazolam
Cohort 2 Probe Cocktail
dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
Cohort 3 Probe Cocktail
bupropion
Eligibility Criteria
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Inclusion Criteria
* ≥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 Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Syneos Health
OTHER
Nuventra, Inc.
INDUSTRY
Emalex Biosciences Inc.
INDUSTRY
Responsible Party
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Locations
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Syneos Health Clinical Research Services, LLC.
Miami, Florida, United States
Countries
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Other Identifiers
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EBS-101-HV-101
Identifier Type: -
Identifier Source: org_study_id
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