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Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite

NCT04902105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-07-22

No results posted yet for this study

Summary

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

Conditions

  • Drug Interaction

Interventions

DRUG

ecopipam HCL

oral tablets

DRUG

Mefenamic acid

oral capsules

DRUG

Divalproex Sodium ER

oral tablets

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
2021-05-13
Primary Completion
2021-07-06
Completion
2021-07-06
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 NCT04902105 on ClinicalTrials.gov