Healthy
Conditions
Keywords
Healthy Volunteers
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.
Interventions
DRUGCVN424
SAD / MAD
DRUGPlacebo
Placebo
Sponsors
Cerevance Beta, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Single ascending dose and multiple ascending dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Urinalysis | Baseline through 14 days post-dose | pH |
| 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 | RBC |
| Evaluation of Vital Signs | Baseline through 14 days post-dose | Oral Temperature (°C ) |
| Evaluation of Electrocardiograms | Baseline through 14 days post-dose | Standard 12-lead ECG - QT 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 | ALT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| RNA isolation and genotyping | 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 |
| DNA isolation and genotyping | 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 |
Countries
United States
Outcome results
None listed