Study of CVN424 in Healthy Subjects

NCT03657030 | Completed Phase 1 FDA Drug

• 1 other identifier: CVN424-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (43)

• Evaluation of adverse events

  Occurrence of all adverse events from signing of informed consent through end of study treatment.

  Baseline through 14 days post-dose

• Evaluation of Hematology

  RBC

  Baseline through 14 days post-dose

• Evaluation of Vital Signs

  Oral Temperature (°C )

  Baseline through 14 days post-dose

• Evaluation of Electrocardiograms

  Standard 12-lead ECG - QT interval

  Baseline through 14 days post-dose

• Evaluation of BMI

  Weight and Height will be combined to calculate BMI using the following formula: BMI = weight (kg)/\[height (m)\]2

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  ALT

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  pH

  Baseline through 14 days post-dose

• Evaluation of Vital Signs

  Respiration rate

  Baseline through 14 days post-dose

• Evaluation of Vital Signs

  Pulse rate

  Baseline through 14 days post-dose

• Evaluation of Vital Signs

  Blood pressure (both systolic and diastolic)

  Baseline through 14 days post-dose

• Evaluation of Hematology

  WBC with differential (%and absolute) platelets, PT/INR

  Baseline through 14 days post-dose

• Evaluation of Hematology

  Hemoglobin

  Baseline through 14 days post-dose

• Evaluation of Hematology

  Hematocrit

  Baseline through 14 days post-dose

• Evaluation of Hematology

  PT/INR

  Baseline through 14 days post-dose

• Evaluation of Hematology

  Platelets

  Baseline through 14 days post-dose

• Evaluation of Electrocardiograms

  Standard 12-lead ECG- QTcB interval

  Baseline through 14 days post-dose

• Evaluation of Electrocardiograms

  Standard 12-lead ECG - QTcF interval

  Baseline through 14 days post-dose

• Evaluation of Electrocardiograms

  Standard 12-lead ECG - RR interval

  Baseline through 14 days post-dose

• Evaluation of Electrocardiograms

  Standard 12-lead ECG - QRS interval

  Baseline through 14 days post-dose

• Evaluation of Electrocardiograms

  Standard 12-lead ECG - PR interval

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Albumin

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Alkaline phosphatase

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Lipase

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  AST

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Total bilirubin

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Direct bilirubin

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Total protein

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Creatinine

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Blood urea nitrogen

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Creatine kinase Glucose, Chloride, Bicarbonate

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  GGT

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Potassium

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Sodium

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Glucose

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Chloride

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Bicarbonate

  Baseline through 14 days post-dose

• Evaluation of Serum Chemistry

  Calcium

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  Specific gravity

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  Protein

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  Glucose

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  Blood

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  Nitrite

  Baseline through 14 days post-dose

• Evaluation of Urinalysis

  Microscopic Analysis (only if positive dipstick results): RBC/high power field, WBC/high power field, Epithelial cells, casts

  Baseline through 14 days post-dose

Secondary Outcomes (4)

• Plasma Concentration (AUC) of CVN424

  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)

• Plasma Concentration (Cmax) of CVN424

  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)

• Food effect by measurement of plasma PK (Cmax)

  Baseline through 14 days post-dose

• Food effect by measurement of plasma PK (AUC)

  Baseline through 14 days post-dose

Other Outcomes (2)

• DNA isolation and genotyping

  Day 1

• RNA isolation and genotyping

  Day 1 and Day 7

Study Arms (2)

Single Ascending Dose

ACTIVE COMPARATOR

The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.

Drug: CVN424; Drug: Placebo

Multiple Ascending Dose

ACTIVE COMPARATOR

The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.

Drug: CVN424; Drug: Placebo

Interventions

CVN424 DRUG

SAD / MAD

Multiple Ascending Dose; Single Ascending Dose

Placebo DRUG

Placebo

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerevance Beta, Inc.: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Study Officials

• David H Margolin, MD, PhD

  Cerevance, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose and multiple ascending dose study

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 4, 2018
• Study Start: September 18, 2018
• Primary Completion: March 1, 2019
• Study Completion: May 30, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)