MedTrace Logo

Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates

NCT04764851 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-24

No results posted yet for this study

Summary

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

Conditions

  • Drug-Interactions

Interventions

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

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Nuventra, Inc.

    collaborator INDUSTRY

  • Emalex Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2021-04-02
Completion
2021-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764851 on ClinicalTrials.gov