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Dopamine D1 Receptor Antagonist

Cohort 1 for Drug Interaction

Phase 1
Waitlist Available
Research Sponsored by Emalex Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 63
Awards & highlights

Study Summary

This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 63
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 63 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
AUC0-24 of dabigatran in the absence of ecopipam
+43 more
Secondary outcome measures
AEs with relatedness associated with IV midazolam
AEs with relatedness associated with atorvastatin
AEs with relatedness associated with bupropion
+130 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 3 Probe Substrate 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
Group II: Cohort 2Experimental Treatment2 Interventions
ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 2 Probe Substrate given on 2 separate days: - bupropion: 100mg oral tablet
Group III: Cohort 1Experimental Treatment2 Interventions
ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 1 Probe Substrate 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecopipam
2019
Completed Phase 2
~460
Cohort 1 Probe Substrate Cocktail
2022
Completed Phase 1
~60
Cohort 3 Probe Substrate Cocktail
2022
Completed Phase 1
~60
Cohort 2 Probe Substrate
2022
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
10 Previous Clinical Trials
836 Total Patients Enrolled
ICON Early Phase ServicesUNKNOWN
NuventraUNKNOWN
2 Previous Clinical Trials
68 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport
2022. "Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05334108.
~19 spots leftby Apr 2025
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