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Renal ImpairmentPhase 1NCT05940402

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

A Phase 1 study testing Emraclidine in people with Renal Impairment, run by AbbVie at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment
What is being tested?
Emraclidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
5 sitesUnited States
Study dates
24 Jul 2023to 19 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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):
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  • Suicidal Ideation Item 1 (Wish to be Dead)
  • Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Any "yes" response on Suicidal Ideation Item 1 or Item 2 that was within the individual's lifetime but not within the past 12 months should be discussed with the medical monitor prior to inclusion of the participant in the trial.
  • Serious risk of suicide in the opinion of the investigator is also exclusionary.
  • 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.
  • Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
  • Participants who require dialysis
  • Participants with nephrotic syndrome.
  • NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Knoxville, Tennessee

    Knoxville, Tennessee, 37920

  • Miami, Florida

    Miami, Florida, 33014

  • Miami, Florida

    Miami, Florida, 33136

  • Orlando, Florida

    Orlando, Florida, 32808

  • Tustin, California

    Tustin, California, 92780

Other trials in United States

About this study

Official title: A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following a Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Renal Impairment Compared With Adult Participants With Normal Renal Function

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.

Being tested
Emraclidine
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmraclidineDrug

    Also called CVL-231

    Oral tablets

Study groups in NCT05940402
Study groupRoleWhat they receive
Mild Renal ImpairmentExperimentalParticipants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.
Receives: Drug: Emraclidine
Moderate Renal ImpairmentExperimentalParticipants will receive a single oral dose of 10 mg emraclidine on Day 1.
Receives: Drug: Emraclidine
Severe Renal ImpairmentExperimentalParticipants will receive a single oral dose of 10 mg emraclidine on Day 1.
Receives: Drug: Emraclidine
Normal Renal FunctionExperimentalParticipants will receive a single oral dose of 10 mg emraclidine on Day 1.
Receives: Drug: Emraclidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of Emraclidine

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

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

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

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

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

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

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

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

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

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

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

Secondary outcomes (6)

  1. Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to Day 15

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

    Measured: Up to Day 5

  3. Number of Participants With Clinically Significant Changes in Vital Signs

    Measured: Up to Day 5

  4. Number of Participants With Clinically Significant Change in Laboratory Assessments

    Measured: Up to Day 5

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

    Measured: Up to Day 5

  6. Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score

    The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.

    Measured: Up to Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start24 Jul 2023
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940402
Sponsor's protocol ID
CVL-231-SP-1007
Status last verified
Apr 2025
First submitted
2 Jul 2023
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Emraclidine in people with Renal Impairment, run by AbbVie at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Emraclidine (time frame: Pre-dose and at multiple timepoints post-dose up to Day 5). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05940402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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