Study of CVN424 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CVN424; Drug: Placebo

• Registration Number: NCT03657030
• Lead Sponsor: Cerevance Beta, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Study Start: 2018-09-18
• Primary Completion: 2019-03-01
• Study Completion: 2019-05-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose	Placebo	The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.
Multiple Ascending Dose	CVN424	The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.
Multiple Ascending Dose	Placebo	The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.
Single Ascending Dose	CVN424	The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.

Primary Outcome Measures

Name	Time	Method
Evaluation of adverse events	Baseline through 14 days post-dose	Occurrence of all adverse events from signing of informed consent through end of study treatment.
Evaluation of Hematology	Baseline through 14 days post-dose	Platelets
Evaluation of Vital Signs	Baseline through 14 days post-dose	Blood pressure (both systolic and diastolic)
Evaluation of Electrocardiograms	Baseline through 14 days post-dose	Standard 12-lead ECG - PR interval
Evaluation of BMI	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
Evaluation of Serum Chemistry	Baseline through 14 days post-dose	Calcium
Evaluation of Urinalysis	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

Name	Time	Method
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)	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)
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)	To evaluate the pharmacokinetics of single and multiple doses of CVN424. Pharmacokinetic parameters including, but not limited to maximum plasma concentration (Cmax).
Food effect by measurement of plasma PK (Cmax)	Baseline through 14 days post-dose	Assess the effect of food on the bioavailability in the current formulation after digesting a high caloric meal.
Food effect by measurement of plasma PK (AUC)	Baseline through 14 days post-dose	Assess the effect of food on the bioavailability in the current formulation after digesting a high caloric meal.

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States