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Drug Interaction Study

NCT06194864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

Conditions

  • Drug Interaction

Interventions

DRUG

Itraconazole

itraconazole 200 mg QD Days 6 to 16

DRUG

rifampicin

rifampicin 600 mg QD Days 6 to 20

DRUG

Ecopipam

89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Cambridge Cognition Ltd

    collaborator INDUSTRY

  • Emalex Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Rick Munschauer, MSc, MD, FAAN · Emalex Biosciences

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
2024-01-18
Primary Completion
2024-05-14
Completion
2024-05-22
FDA Drug
Yes

Countries

  • Canada

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 NCT06194864 on ClinicalTrials.gov