drugset / Trial / NCT04764851
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
Phase 1
Terminated
30 enrolled
Emalex Biosciences Inc.
Nuventra, Inc. · collabSyneos Health · collab
Non-randomizedParallel-groupOpen-labelBasic science
Summary
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Timeline
- Start
- 2021-02-18
- Primary completion
- 2021-04-02
- Completion
- 2021-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 100 ug | Oral |
| Subject | Bupropion | Small molecule | 100 mg | Oral |
| Subject | Caffeine | Small molecule | 200 mg | Oral |
| Subject | Dabigatran | Unknown | 375 ug | Oral |
| Subject | Dextromethorphan | Unknown | 10 mg | Oral |
| Subject | Ecopipam | Small molecule | 2 mg/kg | Oral |
| Subject | Midazolam | Small molecule | 1 ug | Intravenous |
| Subject | Midazolam | Small molecule | 10 ug | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | Oral |
| Subject | Pitavastatin | Small molecule | 10 ug | Oral |
| Subject | Rosuvastatin | Small molecule | 50 ug | Oral |
Indications
No indication recorded.