A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function

NCT05940402 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-231-SP-1007
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief Summary

The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 5

• Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 5

• Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 5

• Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 5

• Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 5

• Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 5

Secondary Outcomes (6)

• Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

  Up to Day 15

• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

  Up to Day 5

• Number of Participants With Clinically Significant Changes in Vital Signs

  Up to Day 5

• Number of Participants With Clinically Significant Change in Laboratory Assessments

  Up to Day 5

• Number of Participants With Clinically Significant Change in Physical and Neurological Examination Results

  Up to Day 5

Study Arms (4)

Mild Renal Impairment

EXPERIMENTAL

Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.

Drug: Emraclidine

Moderate Renal Impairment

EXPERIMENTAL

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Drug: Emraclidine

Severe Renal Impairment

EXPERIMENTAL

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Drug: Emraclidine

Normal Renal Function

EXPERIMENTAL

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Drug: Emraclidine

Interventions

Emraclidine DRUG

Oral tablets

Also known as: CVL-231

Mild Renal Impairment; Moderate Renal Impairment; Normal Renal Function; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For All Participants
• Body mass index of ≥18.0 to 42.0 kilograms per meter square (kg/m\^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds \[lbs\]).
• Sexually active women of childbearing potential must agree to use at least an acceptable birth control method during the trial and for 7 days after the last dose of investigational medicinal product (IMP).
• Additional Criteria for Participants With Normal Renal Function
• Age that is within ±10 years of the median age for the renal impairment groups.
• Body weight that is within ±15% of the median body weight for the renal impairment groups.
• Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator.
• Normal renal function: Estimated glomerular filtration rate (eGFR) ≥90 milliliter per minute (mL/min) determined using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value.
• Additional Criteria for Participants With Renal Impairment
• Mild, moderate, or severe renal impairment based on eGFR determined using the 2021 CKD-EPI equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value.
• Stable disease, defined as no clinically significant changes in disease status as documented by most recent eGFR assessment (within at least 3 months before Screening).
• Stable concomitant medications for the management of individual participant's medical history; on a case-by-case basis, with input from the sponsor, participants receiving fluctuating concomitant medication/treatment may be considered if the underlying disease is under control.

You may not qualify if:

• For All Participants
• "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
• Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods \[Not Plan\] without Intent to Act)
• Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan)
• Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent)
• Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
• Suicidal Ideation Item 1 (Wish to be Dead)
• History of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the informed consent form (ICF).
• Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.
• In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of investigational medicinal product (IMP) will be excluded.
• \- Have recently been diagnosed with symptomatic coronavirus disease-2019 (COVID-19) or test positive (i.e., using polymerase chain reaction \[PCR\] or rapid antigen test) for SARS-CoV-2 within 15 days prior to signing the ICF.
• Additional Criteria for Participants With Normal Renal Function
• \- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for surgically excised non-melanomatous skin cancers or in situ cervical cancer, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
• Additional Criteria for Participants With Renal Impairment
• Evidence of disease that is not explained by current/known medical history, i.e., organ dysfunction (including malignancies) or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with renal impairment and other underlying conditions.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (5)

Tustin, California

Tustin, California, 92780, United States

Location

Miami, Florida

Miami, Florida, 33014, United States

Location

Miami, Florida

Miami, Florida, 33136, United States

Location

Orlando, Florida

Orlando, Florida, 32808, United States

Location

Knoxville, Tennessee

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 11, 2023
• Study Start: July 24, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)