A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105 (NCT03043482) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105
United States69 participantsStarted 2017-01-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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 1.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
Timeframe: 3 weeks
2
Pharmacokinetic (PK) of VS-105 in serum: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 and 16 hours and 2, 3, 7, 8, 9, 14, 15, 16 days after dosing.
3
PK of VS-105 in serum: area under the serum concentration-time curve from time zero to infinity.
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 and 16 hours and 2, 3, 7, 8, 9, 14, 15, 16 days after dosing.
4
PK of VS-105 in serum: observed maximum serum concentration following drug administration
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 and 16 hours and 2, 3, 7, 8, 9, 14, 15, 16 days after dosing.
5
PK of VS-105 in serum: terminal elimination half-life
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 and 16 hours and 2, 3, 7, 8, 9, 14, 15, 16 days after dosing.
6
PK of VS-105 in serum: time to reach the maximum concentration after drug administration
. Subject has end stage renal disease and is on a stable (defined as Kt/V ≥ 1.2 on two occasions within 3 months of screening) HD regimen (prescribed at least 3 times/week) for at least 3 months prior to screening.
. 18 to 75 years of age (inclusive).
Exclusion criteria
. Receiving blood purification therapy other than hemodialysis.
. Dialysis via central venous catheter.
. Expected to undergo pre emptive or scheduled renal transplant within 6 months after Screening.
. Pregnant (positive pregnancy test) or lactating women, and male subjects whose female partners are pregnant or lactating. If serum hCG pregnancy test results are indeterminate, follow up testing should be performed to determine eligibility.
. History of significant gastrointestinal, hepatic, broncho pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis, or any other unstable or new onset medical conditions that, in the opinion of the investigator, would constitute a risk factor for study participation or receipt of study drug.
. History of having received or currently receiving any systemic anti neoplastic (including radiation) or immune modulatory treatment (including systemic oral corticosteroids) ≤ 6 months prior to the first dose of study drug or such treatment is expected to be needed at any time during the study.
. Subjects who have had significant acute infection (eg, influenza, local infection, acute gastrointestinal symptoms) or any other clinically significant illness within 2 weeks prior to the first dose of study drug.
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 and 16 hours and 2, 3, 7, 8, 9, 14, 15, 16 days after dosing.