Study to Assess Adverse Events and How Oral Emraclidine Moves Through the Body of Adult Healthy Volunteers

Purpose

The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.

Condition

  • Healthy Volunteers

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Body mass index of 18.5 to 32.0 kg/m2, inclusive. - Total body weight >= 50 kg.

Exclusion Criteria

  • History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement. - Vital sign measurements, at Screening and Check-in: - Systolic blood pressure >= 140 mmHg or < 100 mmHg - Diastolic blood pressure >= 90 mmHg or < 60 mmHg - Heart rate > 100 bpm or < 50 bpm - Orthostatic hypotension, defined as a decrease of >= 20 mmHg in systolic blood pressure upon standing compared with the supine/sitting blood pressure measurement. - Female participants of childbearing potential

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sequence 1 		Participants will receive Emraclidine in 3 different formulations in Sequence 1.
  • Drug: Emraclidine
    Oral tablet
Experimental
Sequence 2 		Participants will receive Emraclidine in 3 different formulations in Sequence 2.
  • Drug: Emraclidine
    Oral tablet
Experimental
Sequence 3 		Participants will receive Emraclidine in 3 different formulations in Sequence 3.
  • Drug: Emraclidine
    Oral tablet
Experimental
Sequence 4 		Participants will receive Emraclidine in 3 different formulations in Sequence 4.
  • Drug: Emraclidine
    Oral tablet
Experimental
Sequence 5 		Participants will receive Emraclidine in 3 different formulations in Sequence 5.
  • Drug: Emraclidine
    Oral tablet
Experimental
Sequence 6 		Participants will receive Emraclidine in 3 different formulations in Sequence 6.
  • Drug: Emraclidine
    Oral tablet

Recruiting Locations

Acpru /Id# 283349
Grayslake, Illinois 60030

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com