Clinical trial NCT03657030: Study of CVN424 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: CerevanceBeta
Sponsor class: UNKNOWN
First posted: 2018-09-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single ascending dose and multiple ascending dose study
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of adverse events
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Hematology
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Vital Signs
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Electrocardiograms
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of BMI
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Vital Signs
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Vital Signs
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Vital Signs
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Hematology
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Hematology
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Hematology
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Hematology
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Hematology
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Electrocardiograms
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Electrocardiograms
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Electrocardiograms
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Electrocardiograms
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Electrocardiograms
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Serum Chemistry
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
measure: Evaluation of Urinalysis
timeFrame: Baseline through 14 days post-dose
Secondary outcomes:
measure: Plasma Concentration (AUC) of CVN424
timeFrame: 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)
measure: Plasma Concentration (Cmax) of CVN424
timeFrame: 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)
measure: Food effect by measurement of plasma PK (Cmax)
timeFrame: Baseline through 14 days post-dose
measure: Food effect by measurement of plasma PK (AUC)
timeFrame: Baseline through 14 days post-dose
Other outcomes:
measure: DNA isolation and genotyping
timeFrame: Day 1
measure: RNA isolation and genotyping
timeFrame: Day 1 and Day 7
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Cerevance, Inc.
name: David H Margolin, MD, PhD
role: STUDY_DIRECTOR
References: