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Part 1 for Drug Interaction

Phase 1

Recruiting

Research Sponsored by Emalex Biosciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male subjects or female subjects of non-childbearing potential

Aged ≥18 and ≤55 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 30

Awards & highlights

Study Summary

This trial is being conducted at one medical center. It is a study that has two parts and is designed to look at how a drug called ecopipam behaves in the body when it is taken

Who is the study for?

This trial is for healthy individuals to study how ecopipam behaves in the body when taken alone versus with itraconazole or rifampicin. Specific eligibility criteria are not provided, but typically participants must be adults without significant health issues.Check my eligibility

What is being tested?

The study is testing the interactions between ecopipam and two other drugs: itraconazole and rifampicin. It's a Phase 1 trial at one center where subjects take ecopipam alone first, then combined with either of the other drugs.See study design

What are the potential side effects?

Potential side effects aren't listed, but common ones for drug interaction studies may include nausea, headaches, dizziness, or allergic reactions. The exact side effects will depend on how these drugs interact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man or a woman unable to have children.

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I am between 18 and 55 years old.

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My BMI is between 18.5 and 30, and my weight is over 50 kg if male, or over 45 kg if female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 30 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-inf of ecopipam when administered with itraconazole

AUC0-inf of ecopipam when administered with rifampicin

AUC0-inf of ecopipam when administered without itraconazole

+13 more

Secondary outcome measures

AUC0-4 for EBS 101-40853 glucuronide

AUC0-4 for EBS-101-40853

AUC0-4 for ecopipam

+60 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2Experimental Treatment2 Interventions

ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20.

Group II: Part 1Experimental Treatment2 Interventions

ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itraconazole

2017

Completed Phase 2

~780

Ecopipam

2019

Completed Phase 2

~500

rifampicin

2011

Completed Phase 3

~1980

0 / 3Eligibility criteria met

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

13 Previous Clinical Trials

917 Total Patients Enrolled

Syneos HealthOTHER

172 Previous Clinical Trials

68,414 Total Patients Enrolled

Cambridge Cognition LtdIndustry Sponsor

14 Previous Clinical Trials

4,123 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this clinical trial?

"To be eligible for participation in this clinical trial, potential candidates must fall within the age range of 18 to 55 and have no drug interactions. The study aims to recruit a total of 40 individuals."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"According to the information provided by clinicaltrials.gov, this particular clinical trial is no longer seeking participants. The initial posting date was January 1st, 2024, and the most recent update occurred on December 22nd, 2023. However, it's worth noting that there are currently ten other trials actively enrolling patients at this time."

Answered by AI

Is there an age restriction that prevents individuals older than 30 from participating in this research?

"Individuals within the age range of 18 to 55 years are eligible for participation in this clinical trial."

Answered by AI

What is the level of safety associated with Part 1 in regards to human subjects?

"Given that this is a Phase 1 trial, with limited data supporting safety and efficacy, our team at Power rates the safety of Part 1 as a 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Drug Interaction Study

2024. "Drug Interaction Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06194864.