Safety and Pharmacokinetics of VT-1598
Condition: Coccidioidomycosis
MeSH terms: Coccidioidomycosis; Coccidiosis
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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). Cohorts 1 - 4 will run sequentially, but Cohorts 5
      and 6 may be started concurrently. 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.
      VT-1598 will be administered in the following escalation schedule: Cohort 1 will receive 40
      mg dose, Cohort 2 will receive 80 mg dose, Cohort 3 will receive 160 mg dose, Cohort 4 will
      receive 320 mg dose, Cohort 5 will receive 640 mg dose, and Cohort 6 (fed cohort) will
      receive 160 mg dose. 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.
      The secondary objectives of this study are 1) to determine the pharmacokinetic (PK) profile
      in plasma and urine of VT-1598 and its primary metabolite, VT-11134, in healthy adult
      subjects, and 2) to determine the effect of a high-fat, high-calorie meal on the PK profile
      of VT-1598 and VT-11134 when a single oral dose of VT-1598 is given.
    

Intervention name(s): Placebo; VT-1598
Intervention type(s): Other; Drug
Intervention description(s): Placebo will be supplied as matching tablets (to 40 mg and 80 mg VT-1598 tablets) containing the inactive components of VT-1598.; VT-1598 is a novel oral agent for the treatment of fungal infections. It will be supplied as 40 mg and 80 mg tablets.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adults; Healthy; Pharmacokinetics; Phase 1; Safety; Single Oral Doses; Tolerability; VT-1598