Trials / Terminated
TerminatedNCT04764851
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Emalex Biosciences Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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 fasted doses of probe substrate(s) per assigned cohort. On Day 5, Cohort 2 only will receive a second fasted dose of probe substrates. Subjects in cohorts 1, 2, and 3 will receive the final fasted dose of probe substrate(s) on Day 13. Fasted ecopipam administration will begin on Day 5 and will continue through Day 17 at \~2mg/kg for all cohorts. Ecopipam doses will be tapered starting on Day 18 by 25 mg/day increments until subjects are off drug, with final discharge occurring 24 hours after the ecopipam HCl dose has been reduced to 25 mg (Day 21, 23, or 25).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ecopipam HCl ~2mg/kg/day | oral tablet |
| COMBINATION_PRODUCT | Cohort 1 Probe Cocktail | dextromethorphan, caffeine, omeprazole, and midazolam |
| COMBINATION_PRODUCT | Cohort 2 Probe Cocktail | dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam |
| COMBINATION_PRODUCT | Cohort 3 Probe Cocktail | bupropion |
Timeline
- Start date
- 2021-02-18
- Primary completion
- 2021-04-02
- Completion
- 2021-05-07
- First posted
- 2021-02-21
- Last updated
- 2021-05-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04764851. Inclusion in this directory is not an endorsement.