A Phase 1, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105 Following Oral Administration in Healthy and Hemodialysis Subjects

Vidasym, Inc.1 site in 1 country69 target enrollmentJanuary 24, 2017

ConditionsChronic-kidney Disease Stage 5D on Stable Hemodialysis

InterventionsSingle VS-105/placebo to healthy Multiple VS-105/placebo to healthy Multiple VS-105/placebo to HD subjects

DrugsSingle VS-105/placebo to healthy Multiple VS-105/placebo to healthy Multiple VS-105/placebo to HD subjects

Overview

Phase: Phase 1
Intervention: Single VS-105/placebo to healthy
Conditions: Chronic-kidney Disease Stage 5D on Stable Hemodialysis
Sponsor: Vidasym, Inc.
Enrollment: 69
Locations: 1
Primary Endpoint: Safety and tolerability of single and multiple ascending doses of VS 105 administered orally to healthy and HD subjects (numbers and percentages of adverse events).
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, and PK following single and multiple ascending dose administration of VS-105 in healthy subjects and patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.

Detailed Description

This is a first in human, 3 part, single and multiple ascending dose study in healthy subjects and subjects with end stage renal disease (ESRD) requiring hemodialysis (HD). A Safety Monitoring Committee (SMC) will evaluate safety data from each dose cohort before proceeding with the subsequent cohort. The SMC will also review data from each Part of the study before proceeding to the next scheduled Part. In Part 1, single ascending doses (SAD) of VS 105 will be administered to approximately 5 dose cohorts of 8 healthy subjects each. In Part 2, multiple ascending doses (MAD) of VS 105 will be administered to approximately 3 dose cohorts of 8 healthy subjects each. VS 105 doses for MAD cohorts in Part 2 will be determined by the SMC and based on results from Part 1. In Part 3, MAD of VS 105 will be administered to approximately 3 successive dose cohorts that will each include 4 subjects with ESRD requiring HD. VS 105 doses used in Part 3 will be selected by the SMC based on review of safety and/or pharmacokinetic (PK) results from Part 1 and Part 2. Parts 1 \& 2 of the study will assess the safety, tolerability, and PK of ascending doses of VS 105 to determine the dose range that is safe and well tolerated in healthy subjects. Part 3 of the study will assess the safety, tolerability, and PK of various doses of VS 105 in subjects with ESRD requiring HD (ie, HD subjects), who represent the target population with secondary hyperparathyroidism (SHPT).

Registry

clinicaltrials.gov

Start Date

January 24, 2017

End Date

March 31, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vidasym, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Subjects (Parts 1 \& 2)
•Eligible healthy subjects must meet all of the following criteria to quality for enrollment in this study:
•Healthy male and female subjects between 18 and 60 years of age (inclusive). Healthy status, as determined by the investigator, will be based on medical and surgical history, as well as a complete physical examination including vital signs, electrocardiogram (ECG), and laboratory test results.
•A body mass index (BMI) between 18 and 35 kg/m2 (inclusive).
•Female subjects of childbearing potential must be non pregnant and non lactating, and have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test on Day 1 (if initial serum human chorionic gonadotropin \[hCG\] test results are indeterminate, follow up testing should be performed). Female subjects of childbearing potential (including perimenopausal women who have had menstrual bleeding within 1 year) must be using a method of birth control considered to be appropriate by the investigator (eg, abstinence, double barrier methods, hormonal contraceptives, or partner with vasectomy) for the entire duration of the trial. Female subjects of childbearing potential must agree to use appropriate birth control from the time of Screening until at least 1 month after their last dose of study drug.
•Women are considered to be not of childbearing potential if they are postmenopausal (defined as amenorrheic for ≥12 months with a confirmed follicle stimulating hormone \[FSH\] ≥ 40 mIU/mL) or if they have been surgically sterilized.
•Male subjects must either: remain abstinent from intercourse, be sterile, or agree to use a method of birth control considered to be appropriate by the investigator (eg, condom with spermicide) from the time of Screening until 1 month after their last dose of study drug.
•Non smoker (and no use of other tobacco or nicotine containing products) as documented by history (no nicotine use over the past 6 months) and a negative cotinine test at Screening and Day
•Capable of understanding the written informed consent form (ICF) and providing signed and witnessed written informed consent, as well as willing and able to comply with protocol requirements.
•Hemodialysis Subjects (Part 3)

Exclusion Criteria

Not provided

Arms & Interventions

Single VS-105/placebo to healthy

Single ascending dose VS-105 or placebo to healthy subjects

Intervention: Single VS-105/placebo to healthy

Multiple VS-105/placebo to healthy

Multiple ascending dose VS-105 or placebo to healthy subjects

Intervention: Multiple VS-105/placebo to healthy

Multiple VS-105/placebo to HD subjects

Multiple ascending dose VS-105 or placebo to hemodialysis (HD) subjects

Intervention: Multiple VS-105/placebo to HD subjects

Outcomes

Primary Outcomes

Safety and tolerability of single and multiple ascending doses of VS 105 administered orally to healthy and HD subjects (numbers and percentages of adverse events).

Time Frame: 3 weeks

Adverse events will be counted within each treatment and study part. The numbers and percentages of adverse events will be tabulated by body system, preferred term, and severity.

PK of VS-105 in serum: area under the serum concentration-time curve from time zero to infinity.