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OpenTrials
Completed

NCT Number: NCT06722430

A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants

This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 271617

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion criteria

  • History of any clinically significant sensitivity or allergy to any medication or food.
  • Exposure to icalcaprant within the past 90 days.
  • 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.].

Treatment and study plan

Icalcaprant

Drug

Oral capsule

Other names: ABBV-1354, CVL-354

Itraconazole (ITZ)

Drug

Oral capsule

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Icalcaprant

    Time frame: Up to approximately 14 days

    Cmax of Icalcaprant

  2. Time to Cmax (Tmax) of Icalcaprant

    Time frame: Up to approximately 14 days

    Tmax of Icalcaprant

  3. Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant

    Time frame: Up to approximately 14 days

    Beta of Icalcaprant

  4. Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant

    Time frame: Up to approximately 14 days

    T1/2 of Icalcaprant

  5. Area under the plasma concentration-time curve (AUC) of Icalcaprant

    Time frame: Up to approximately 14 days

    AUC of Icalcaprant

  6. Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant

    Time frame: Up to approximately 14 days

    AUCt of Icalcaprant

  7. Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant

    Time frame: Up to approximately 14 days

    AUCinf of Icalcaprant

  8. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 47 days

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Open-label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Icalcaprant in Healthy Adult Subjects

Acronym: 529 DDI ITZ

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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