Relative Bioavailability and Food Effect Study of CVN424

NCT05635461 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CVN424-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension and Tablet Formulations in Healthy Volunteers Under Fasted and Fed Conditions.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (5)

• Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measured Non Zero Concentration (AUC0-t) of CVN424 Suspension Fasted and Tablet Fasted

  Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Area Under the Plasma Concentration Time Curve From Time 0 to 96 Hours (AUC 0-96h) of CVN424 Suspension Fasted and Tablet Fasted

  Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of CVN424 Suspension Fasted and Tablet Fasted

  Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Time to Reach Cmax (Tmax) of CVN424 Suspension and Tablet

  Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Time Taken for Drug to Appear in Systemic Circulation Following Administration (Tlag) of CVN424 Suspension and Tablet

  Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

Secondary Outcomes (6)

• AUC(0-t) of CVN424 Tablet Fed and Tablet Fasted

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• AUC(0-96 Hrs) of CVN424 Tablet Fed and Tablet Fasted

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Cmax of CVN424 Tablet Fed and Tablet Fasted

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Tmax of CVN424 Tablet Fed and Tablet Fasted

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

• Tlag of CVN424 Tablet Fed and Tablet Fasted

  Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose

Study Arms (3)

Suspension (fasted)

ACTIVE COMPARATOR

150 milligrams (mg) of CVN424 administered in a single dose of suspension formulation.

Drug: CVN424

Tablet (fed)

ACTIVE COMPARATOR

150 milligrams (mg) tablet of CVN424 administered in a single dose after ingestion of a standardized high-fat, high-calorie meal according to FDA Guidance for Industry (Food-effect bioavailability and fed bioequivalence studies, Jun 2022).

Drug: CVN424

Tablet (fasted)

ACTIVE COMPARATOR

150 milligrams (mg) tablet of CVN424 administered in a single dose.

Drug: CVN424

Interventions

CVN424 DRUG

150 mg of either tablet or suspension formulation

Suspension (fasted); Tablet (fasted); Tablet (fed)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the Investigator's opinion, the participant can understand and sign the Informed Consent Form (ICF) and comply with all protocol requirements.
• The participant is male or female adult who is 18 to 55 years of age, inclusive at the time of Screening.
• Participant weighs at least 45 kilograms (kg) (99 pounds \[lbs\]) and has a BMI between 18.0 and 35.0 kg/m2, inclusive at Screening.
• The participant is medically healthy with no clinically significant (CS) or relevant abnormalities in medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.
• Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use two methods of adequate and reliable contraception (see Section 9.1.12) throughout the study and at least 12 weeks after the last dose of study drug has been taken.

You may not qualify if:

• Vegetarian, Vegan, Lactose intolerant, or follows a Kosher diet.
• Evidence of clinically significant neurologic or other disorder or impairment that, in the opinion of the Investigator, is reasonably expected to impact the ability of the participant to participate or confound the study results.
• A current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption \[e.g., bariatric surgery or bowel resection\]). Note, history of cholecystectomy is permitted if there is no evidence of malabsorption per the Investigator.
• A history of cancer or other malignancy, with the exception of low-grade cervical intraepithelial neoplasia, low-grade (low-risk) prostate cancer, or 5-year cancer-free survivors of basal or squamous cell carcinoma or higher-grade cervical intraepithelial neoplasia or prostate cancer.
• A positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or a human immunodeficiency virus (HIV) infection at Screening.
• Any clinically significant abnormalities in labs: biochemistry (including liver function test \[LFT\], estimated glomerular filtration rate \[eGFR\], and glucose), hematology with white blood cell (WBC) differential, c-reactive protein (CRP), coagulation tests, lipase, amylase, albumin, and calcium.
• A supine blood pressure outside the ranges of 80 to 160 mm Hg for systolic and 50 to 100 mm Hg for diastolic, confirmed with up to two repeat tests at the Screening Visit; or symptomatic orthostatic hypotension, in the opinion of the Investigator.
• A resting heart rate outside the range of 40 to 100 beats per minute (bpm) confirmed with up to two repeat tests at the Screening Visit. Note that 40-50 and 90-100 bpm may be permitted only at the discretion of the Investigator.
• Positive urine result for illegal drugs at Screening and Check-In, or history of illicit drug use or alcohol abuse within 1 year prior to the Screening Visit.
• Received any investigational compound (defined as a drug that has not been FDA-approved) within 30 days prior to the first dose of study medication or within 5 half-lives of the investigational compound, whichever is greater.
• Within 14 or 28 days prior to randomization, ingested any of the following excluded medication, supplements, or food products: St. John's wort, ginseng, kava, Ginkgo biloba, Chinese herbs, and melatonin, or known strong inhibitors/inducers of cytochrome P-4503A4/5, including rifampin, clarithromycin, ketoconazole, itraconazole. For full list of prohibited medications and dietary products, (See Table 2 in full protocol).
• Regularly uses nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum). The casual users (≤ 10 cigarettes/week) may participate; however, they must agree to refrain from 30 days before Day 0 (Inpatient Check-in) for the duration of the study or a positive urine cotinine test at Inpatient Check-in.
• Known history of coronary artery disease and hospitalization for myocardial infraction, ischemic heart disease, or congestive heart failure within the 2 years prior to the screening visit.
• Any clinically significant medical, psychiatric, or laboratory abnormality that, in the judgment of the Investigator, is likely to interfere with study participation.
• A history of major depression or risk of suicide according to the Investigator's clinical judgment or has made a suicide attempt.

Sponsors & Collaborators

• Cerevance Beta, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Michelle Charles, Executive Director Regulatory Affairs
• Organization: Cerevance

michelle.charles@cerevance.com

(408) 220-5722

Study Officials

• Dr. Martin Bexon, MD

  Cerevance Beta, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 2, 2022
• Study Start: October 9, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 21, 2022
• Last Updated: September 19, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)