Thorough QT/QTc of Pritelivir in Healthy Subjects

HSV Infection Clinical Trial

Official title: A Double-blind, Single-center, Randomized, Placebo- and Positive-controlled, Parallel-group Trial With a Nested Crossover Part on the Electrocardiographic Effects 100 and 400 mg Pritelivir Per Day in Healthy Subjects: a Thorough QT/QTc Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Herpes Simplex
• HSV Infection

• NCT number: NCT05671029
• Study type: Interventional
• Source: AiCuris Anti-infective Cures AG
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2022
• Completion date: May 18, 2023