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Drug Interaction Study in Healthy Subjects (529 DDI ITZ Trial)

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 47 days
Awards & highlights
No Placebo-Only Group

Summary

"This trial will investigate how itraconazole, a medication that affects how other drugs are metabolized in the body, influences the effects of a single dose of icalcaprant in healthy individuals."

Who is the study for?
This trial is for healthy adults. Specific details about who can join are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.
What is being tested?
The study is testing how the drug Icalcaprant behaves in the body when taken with another drug called Itraconazole. Participants will receive a single dose of Icalcaprant to see if there's any change when it's combined with a strong CYP3A inhibitor like Itraconazole.
What are the potential side effects?
While specific side effects aren't listed, common ones for new drugs may include nausea, headaches, dizziness, or allergic reactions. The safety and tolerability of this combination will also be closely monitored throughout the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition or had surgery that could affect my stomach or intestine's function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 47 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 47 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the plasma concentration-time curve (AUC) of Icalcaprant
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Icalcaprant with ItraconazoleExperimental Treatment2 Interventions
Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
1,039 Previous Clinical Trials
523,349 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
460 Previous Clinical Trials
164,134 Total Patients Enrolled
~0 spots leftby Jan 2025
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