A Single Dose Study to Assess Adverse Events and How Oral Icalcaprant Moves Through the Body in Healthy Adult Japanese and Han Chinese Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
AbbVie
Study ID
NCT06722417
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study will assess the pharmacokinetics, safety, and tolerability of icalcaprant administered orally in healthy adult Japanese and Han Chinese participants.

Key Dates

Start date
Nov 26, 2024
Status verified
Jan 2025
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: Icalcaprant Dose A- Japanese Participants
    Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period.
  • Experimental: Group 2: Icalcaprant Dose A- Han Chinese Participants
    Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Icalcaprant [ Time Frame: Up to approximately 6 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials, LLC /ID# 271323AnaheimCalifornia92801-

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By research site
Anaheim Clinical Trials, LLC· Anaheim, CA

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