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Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport

NCT05334108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-12-12

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 Interaction

Interventions

DRUG

Ecopipam

ecopipam HCl \~2mg/kg/day

COMBINATION_PRODUCT

Cohort 1 Probe Substrate Cocktail

dextromethorphan, caffeine, omeprazole, and midazolam

DRUG

Cohort 2 Probe Substrate

bupropion

COMBINATION_PRODUCT

Cohort 3 Probe Substrate Cocktail

dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

Sponsors & Collaborators

  • ICON Early Phase Services

    collaborator UNKNOWN

  • 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
2022-04-26
Primary Completion
2022-08-01
Completion
2022-08-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05334108 on ClinicalTrials.gov