Thorough QT/QTc of Pritelivir in Healthy Subjects
Condition: HSV Infection
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 clinical trial is a double-blind, single-center, randomized, placebo- and
      positive-controlled, parallel-group, 'nested crossover' trial with multiple oral dose
      administration of pritelivir or matching placebo as well as a single oral administration of
      moxifloxacin (positive control) and corresponding matching placebo in healthy male and female
      subjects.
    

Detailed description: 
      Subjects will be in-house from Day -2 to Day 20 and will be randomized to one of the 2
      parallel treatment groups (as part of the blind, both groups will receive the same number of
      tablets and capsules at the same timepoints, though some will be verum and some will be
      placebo depending on the randomized regimen). Group 1 will receive a therapeutic and a
      supra-therapeutic dose of pritelivir plus moxifloxacin placebo. Group 2 will receive
      pritelivir placebo as well as moxifloxacin and matching placebo (nested crossover: Group 2a
      and Group 2b). 12-lead electrocardiogram (ECG) triplicates will be recorded from the bedside
      12-lead ECG on the Days -1, 1, 2, 6, 16, and 17 and will be analyzed afterwards in each group
      for these 6 days of documentation by a blinded reader.

      It is of note that Holter ECG data will be collected in parallel at Screening to exclude
      anyone with pre-existing cardiac abnormalities as well as on Days -1, 1, 2, 6, 16, and 17 as
      a back-up for the bedside 12-lead ECGs.

      In Group 1, 32 male and female subjects (at least 12 subjects per sex) will receive a loading
      dose of 400 mg pritelivir on Day 1. Afterwards they will receive 100 mg pritelivir qd from
      Day 2 to 6 and 400 mg pritelivir qd from Day 7 to 16. Furthermore, these subjects will
      receive matching moxifloxacin placebo on the Days 2 and 17.

      In Group 2, 32 male and female subjects (at least 12 subjects per sex) will receive the
      respective amounts of tablets of matching pritelivir placebo from Day 1 to Day 16 in Group 2
      as verum tablets in Group 1. Furthermore, subjects in Group 2a (16 male and female subjects)
      will receive 400 mg moxifloxacin on Day 2 and matching moxifloxacin placebo on Day 17 and
      subjects in Group 2b (16 male and female subjects) will receive 400 mg moxifloxacin on Day 17
      and matching moxifloxacin placebo on Day 2.

      To maintain double-blinding the following measures will be needed, and data evaluations
      generated for Group 1 and Group 2:

        -  12-lead ten second ECG triplicates will be digitally recorded and analyzed (from the
           bedside 12-lead-ECG devices) in subjects of both groups on the Days -1, 1, 2, 6, 16 and
           17.

        -  PK samples will be collected from subjects of both groups on the Days 1, 6, and 16 for
           pritelivir and the metabolites AIC090015 and AIC090105 as well as for moxifloxacin on
           the Days 2 and 17.

        -  Over-encapsulated moxifloxacin- and matching placebo will be used.
    

Intervention name(s): Pritelivir and moxifloxacin placebo; Pritelivir placebo, moxifloxacin and moxifloxacin placebo; Pritelivir placebo, moxifloxacin placebo and moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral administration
Intervention MeSH terms: Moxifloxacin; Pritelivir; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention