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

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT06722430
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Icalcaprant — DRUG
    Oral capsule
  • Itraconazole (ITZ) — DRUG
    Oral capsule

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Jan 2025
Primary completion
Jan 13, 2025
Completion
Jan 13, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Icalcaprant with Itraconazole
    Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Icalcaprant [ Time Frame: Up to approximately 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 271617GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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