This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy adult subjects ages 18 - 45 years inclusive. It is designed to evaluate the safety and PK of single oral doses of VT-1598. Forty-eight subjects will be enrolled in the study at 1 site in the US and randomized to receive either VT-1598 or placebo in 6 dosage cohorts (five fasted cohorts and one fed cohort). Each cohort will have 8 subjects; 6 subjects will receive a single oral dose of VT-1598 and 2 subjects will receive matching placebo. Cohorts 1 - 5 will include 2 sentinel subjects randomized to different treatments. Cohort 6 (receiving treatment after being fed a high-calorie, high-fat meal) will not include sentinel subjects. Subjects will be admitted to the study site before dosing and remain at the study site for safety monitoring and PK assessments for at least 72 hours post-dose. Subjects will return to the study site on study Days 7, 14, and 21 for outpatient safety monitoring and PK assessments. There are no formal hypotheses being tested in this Phase 1 trial study. The primary objectives of this study are 1) to determine the safety of single-ascending oral doses of VT-1598 in healthy adult subjects in a fasted state, and 2) to determine the safety of single oral dose of VT-1598 in healthy adult subjects in a fed state.
Age range
18 Years – 45 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Unsolicited Adverse Events
Timeframe: Day 1 through Day 21
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results
Timeframe: Baseline (Day -1) through Day 21
Number of Participants With Abnormal Hematology Laboratory Toxicity Results
Timeframe: Baseline (Day -1) through Day 21
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results
Timeframe: Baseline (Day -1) through Day 21
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results
Timeframe: Baseline (Day -1) through Day 21
Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results
Timeframe: Day 1 through Day 21
Number of Participants With Abnormal Vital Signs
Timeframe: Baseline (Day -1) through Day 21