QT Study to Evaluate the Effect of VT-1161 in Healthy Adult Females

• Research type

  Research Study

• Full title

  A Phase I, Randomized, Double-blind, Placebo and Active Controlled, Nested Crossover Design Thorough QT Study to Evaluate the Effect of VT-1161 on the QTc Interval in Healthy Adult Female Subjects

• IRAS ID

  285421

• Contact name

  Sunu Valasseri

• Contact email

  sunu.valasseri@celerion.com

• Sponsor organisation

  Mycovia Pharmaceuticals

• Eudract number

  2020-002823-12

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  Research Summary

  VT-1161 is being developed for the treatment of patients with fungal infections.
  The purpose of this study is to investigate whether VT-1161 has any effect on the electrical activity of heart. The effects will be compared with moxifloxacin (a drug known to cause changes in electrical activity of heart) and Placebo (dummy drug).
  The duration of individual subject participation, from start of Screening through final follow-up, will be approximately 6.5 weeks. Pre-study screening for eligibility will occur up to 4 weeks before the first dose of investigational medicinal product (IMP). Subjects will be admitted to the CRU two days before dosing (Day -2) to allow for a 8-hour fast before dosing in Day -1. On Day -2, subjects will be admitted to the Clinical Research Unit (CRU) where they will remain for 18 days.
  There will be three dosing cohorts as described below.
  Cohort 1 (Active Treatment Arm): VT-1161 600 mg will be administered on Days 1 – 13 with a 1200 mg dose on Day 14. A single dose of VT-1161 matching placebo will be administered on Day -1 and Day 15. A single dose of moxifloxacin-matching placebo will be administered on Days 1 and 15.
  Cohort 2A Control (Moxifloxacin/Placebo): A single dose of 400 mg moxifloxacin will be administered on Day 1 and moxifloxacin-matching placebo will be given on Day 15. On Days -1, 1 to 14, and 15 VT-1161 matching placebo will be administered.
  Cohort 2B Control (Placebo/Moxifloxacin):VT-1161 matching placebo will be administered on Days -1, 1 to 14 and 15. A moxifloxacin-matching placebo will be given on Day 1. A single dose of 400 mg moxifloxacin will be administered on Day 15

  Summary of Results

  A thorough QT study was conducted to evaluate the effect of oteseconazole on the QTc interval in healthy adult female subjects. That study concluded that oteseconazole, at the studied doses, had no clinically relevant effect on heart rate or beating pattern. Based on this analysis, a QTc effect (ΔΔQTcF) exceeding 10 ms can be excluded at the blood concentration of oteseconazole up to ~18100 ng/mL, more than 5 times the therapeutic exposure of approximately 3500 ng/mL for the approved RVVC indication. These results constitute a negative TQT study, as described in the ICH E14 clinical guidance document.

• REC name

  HSC REC A

• REC reference

  20/NI/0082

• Date of REC Opinion

  3 Jul 2020

• REC opinion

  Favourable Opinion