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Study of CVN424 in Healthy Subjects (CVN424)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657030
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Cerevance Beta, Inc.

Brief Summary:
This is a phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose ascending study in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: CVN424 Drug: Placebo Phase 1

Detailed Description:

Part 1: Single-Dose Regimen and Fasted-Fed Crossover - For the single-dose regimen, approximately 40 healthy male and female subjects will be enrolled in 1 of 5 single dose cohorts (designated as S1 through S5, respectively) in an ascending fashion.

Part 2: Multiple-Dose Regimen

- For the multiple-dose regimen, approximately 24 healthy male and female subjects age 18 to 50 years old will be enrolled in 1 of the 3 multiple-dose cohorts (designated as M1 through M3, respectively) in an ascending fashion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single ascending dose and multiple ascending dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN424 in Healthy Subjects
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : May 30, 2019

Arm Intervention/treatment
Active Comparator: Single Ascending Dose
The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.
Drug: CVN424
SAD / MAD

Drug: Placebo
Placebo

Active Comparator: Multiple Ascending Dose
The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.
Drug: CVN424
SAD / MAD

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Evaluation of adverse events [ Time Frame: Baseline through 14 days post-dose ]
    Occurrence of all adverse events from signing of informed consent through end of study treatment.

  2. Evaluation of Hematology [ Time Frame: Baseline through 14 days post-dose ]
    RBC

  3. Evaluation of Vital Signs [ Time Frame: Baseline through 14 days post-dose ]
    Oral Temperature (°C )

  4. Evaluation of Electrocardiograms [ Time Frame: Baseline through 14 days post-dose ]
    Standard 12-lead ECG - QT interval

  5. Evaluation of BMI [ Time Frame: Baseline through 14 days post-dose ]
    Weight and Height will be combined to calculate BMI using the following formula: BMI = weight (kg)/[height (m)]2

  6. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    ALT

  7. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    pH

  8. Evaluation of Vital Signs [ Time Frame: Baseline through 14 days post-dose ]
    Respiration rate

  9. Evaluation of Vital Signs [ Time Frame: Baseline through 14 days post-dose ]
    Pulse rate

  10. Evaluation of Vital Signs [ Time Frame: Baseline through 14 days post-dose ]
    Blood pressure (both systolic and diastolic)

  11. Evaluation of Hematology [ Time Frame: Baseline through 14 days post-dose ]
    WBC with differential (%and absolute) platelets, PT/INR

  12. Evaluation of Hematology [ Time Frame: Baseline through 14 days post-dose ]
    Hemoglobin

  13. Evaluation of Hematology [ Time Frame: Baseline through 14 days post-dose ]
    Hematocrit

  14. Evaluation of Hematology [ Time Frame: Baseline through 14 days post-dose ]
    PT/INR

  15. Evaluation of Hematology [ Time Frame: Baseline through 14 days post-dose ]
    Platelets

  16. Evaluation of Electrocardiograms [ Time Frame: Baseline through 14 days post-dose ]
    Standard 12-lead ECG- QTcB interval

  17. Evaluation of Electrocardiograms [ Time Frame: Baseline through 14 days post-dose ]
    Standard 12-lead ECG - QTcF interval

  18. Evaluation of Electrocardiograms [ Time Frame: Baseline through 14 days post-dose ]
    Standard 12-lead ECG - RR interval

  19. Evaluation of Electrocardiograms [ Time Frame: Baseline through 14 days post-dose ]
    Standard 12-lead ECG - QRS interval

  20. Evaluation of Electrocardiograms [ Time Frame: Baseline through 14 days post-dose ]
    Standard 12-lead ECG - PR interval

  21. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Albumin

  22. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Alkaline phosphatase

  23. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Lipase

  24. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    AST

  25. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Total bilirubin

  26. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Direct bilirubin

  27. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Total protein

  28. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Creatinine

  29. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Blood urea nitrogen

  30. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Creatine kinase Glucose, Chloride, Bicarbonate

  31. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    GGT

  32. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Potassium

  33. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Sodium

  34. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Glucose

  35. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Chloride

  36. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Bicarbonate

  37. Evaluation of Serum Chemistry [ Time Frame: Baseline through 14 days post-dose ]
    Calcium

  38. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    Specific gravity

  39. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    Protein

  40. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    Glucose

  41. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    Blood

  42. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    Nitrite

  43. Evaluation of Urinalysis [ Time Frame: Baseline through 14 days post-dose ]
    Microscopic Analysis (only if positive dipstick results): RBC/high power field, WBC/high power field, Epithelial cells, casts


Secondary Outcome Measures :
  1. Plasma Concentration (AUC) of CVN424 [ Time Frame: SAD: PK Collection on Day 1-4, and early termination (up to 8 days); MAD: PK Collection on Day 1-10, and early termination (up to 14 days) ]
    To evaluate the pharmacokinetics of single and multiple doses of CVN424. Pharmacokinetic parameters including, but not limited to area under the plasma concentration-time curve (AUC) from 0 to 24hours (AUC0-24)

  2. Plasma Concentration (Cmax) of CVN424 [ Time Frame: SAD: PK Collection on Day 1-4, and early termination (up to 8 days); MAD: PK Collection on Day 1-10, and early termination (up to 14 days) ]
    To evaluate the pharmacokinetics of single and multiple doses of CVN424. Pharmacokinetic parameters including, but not limited to maximum plasma concentration (Cmax).

  3. Food effect by measurement of plasma PK (Cmax) [ Time Frame: Baseline through 14 days post-dose ]
    Assess the effect of food on the bioavailability in the current formulation after digesting a high caloric meal.

  4. Food effect by measurement of plasma PK (AUC) [ Time Frame: Baseline through 14 days post-dose ]
    Assess the effect of food on the bioavailability in the current formulation after digesting a high caloric meal.


Other Outcome Measures:
  1. DNA isolation and genotyping [ Time Frame: Day 1 ]

    Drug metabolic enzyme and transporter polymorphisms that may contribute to variability in CVN424 will be reported.

    Single-dose -pre-dose

    Multi-dose

    -pre-dose


  2. RNA isolation and genotyping [ Time Frame: Day 1 and Day 7 ]

    Single-dose -pre-dose, 8 and 24 hours post dose

    Multi-dose

    -pre-dose, 8 and 24 hours post dose




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
  • The subject signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
  • Subject is a healthy male or female adult who is 18 to 50 years of age inclusive at the time of ICF and study drug dosing.
  • Subject weighs at least 45 kg (99 lbs) and has a BMI between 18.0 and 30.0 kg/m2, inclusive at Screening.
  • A male subject who is nonsterilized and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of the ICF throughout the duration of the study and for 12 weeks after last dose.
  • A female subject with no childbearing potential, defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and FSH>40 IU/L).

Exclusion Criteria:

  • Subjects have a known hypersensitivity to any component of the formulation of CVN424.
  • Subjects have evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, psychiatric disorder, or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
  • There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a condition that might interfere with the conduct or interpretation of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657030


Locations
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United States, Texas
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Cerevance Beta, Inc.
Investigators
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Study Director: David H Margolin, MD, PhD Cerevance, Inc.
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Responsible Party: Cerevance Beta, Inc.
ClinicalTrials.gov Identifier: NCT03657030    
Other Study ID Numbers: CVN424-101
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cerevance Beta, Inc.:
Healthy Volunteers