Thorough QT/QTc of Pritelivir in Healthy Subjects

NCT05671029 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AIC316-03-I-07
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1 clinical trial was a double-blind, single-center, randomized and placebo-controlled trial in which healthy male and female subjects received in 2 parallel-groups daily oral doses of pritelivir (Group 1) or matching placebo (Group 2). Within Group 2, a single oral administration of moxifloxacin (positive control) and corresponding matching placebo was administered in a 2-sequence crossover design (nested crossover).

Conditions

Healthy Subjects

Keywords

Pritelivir, QT, QTc, thorough QT study

Outcome Measures

Primary Outcomes (1)

• Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.

  Mean QTcF values using the Frederica correction method derived from 12-lead ECGs were used to define the effects of pritelivir in comparison with placebo in male and female subjects.

  Day -2 to Day 20

Study Arms (3)

Group 1

EXPERIMENTAL

Subjects (32 male and female subjects) received 400 mg pritelivir on Day 1, 100 mg pritelivir from Day 2 to 6 and 400 mg pritelivir from Day 7 to 16. Furthermore, these subjects received moxifloxacin matching placebo on the Days 2 and 17.

Drug: Pritelivir and moxifloxacin placebo

Group 2a

EXPERIMENTAL

Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2a as verum tablets in Group1. Furthermore, these subjects received 400 mg moxifloxacin on Day 2 and moxifloxacin matching placebo on Day 17.

Drug: Pritelivir placebo, moxifloxacin and moxifloxacin placebo

Group 2b

EXPERIMENTAL

Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2b as verum tablets in Group1. Furthermore, these subjects received moxifloxacin matching placebo on Day 2 and 400 mg moxifloxacin on Day 17.

Drug: Pritelivir placebo, moxifloxacin placebo and moxifloxacin

Interventions

Pritelivir and moxifloxacin placebo DRUG

oral administration

Group 1

Pritelivir placebo, moxifloxacin and moxifloxacin placebo DRUG

oral administration

Group 2a

Pritelivir placebo, moxifloxacin placebo and moxifloxacin DRUG

oral administration

Group 2b

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject had been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which they may be exposed and had given written consent to participation in the trial prior to trial start and any trial-related procedure.
• Healthy male and female subjects of any ethnic origin, aged between 18 and 45 years (inclusive). Assessed as healthy based on a Screening examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results.
• Male subjects were not planning to father or to donate sperms for in vitro fertilization during the trial and for at least 3 months after dosing of trial medication. Adequate contraception (see below) had to be used during sexual intercourse with women of childbearing potential to make sure the fathering of a child was ruled out during the trial and during the 3 months after dosing of trial medication.
• Women of childbearing potential had to perform adequate contraception. They should also not have donated ova during the trial and for at least 3 months after dosing of trial medication.
• Adequate contraception was defined as a combination of a highly effective method of birth control and additional barrier contraception. Highly effective method of birth control was defined as follows: combined (estrogen and progesterone) oral contraceptives, combined hormonal vaginal rings, hormone implants, hormone injectables, or intrauterine device that needed to be in place for a period of at least 2 months prior to Screening and continue for at least 3 months after dosing of trial medication. Additional barrier contraception (the following methods were allowed: condom of the male, diaphragm with spermicide, cervical cap with spermicide) had to be used for the duration of the trial, defined as from the time of Screening to the End of Trial examination, and for at least 3 months after dosing of trial medication. A single barrier method alone or abstinence alone was not acceptable. Homosexual female subjects who refrained from heterosexual intercourse for at least 3 months prior to Screening could be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the End of Trial examination, and for at least 3 months after dosing of trial medication.
• Women of non-childbearing potential could be included if surgically sterile (documented complete hysterectomy, supracervical hysterectomy or bi-tubal ligations; partial hysterectomy was not sufficient) or if postmenopausal (who have a history of no menses of at least 24 months at screening and postmenopausal status was confirmed by follicle stimulating hormone \[FSH\] test at screening).
• In women, negative serum β-HCG (beta-human chorionic gonadotropin) test at Screening and negative urine β-HCG test on Day -2.
• Subject agreed to pharmacogenomic blood sampling.
• Subject had to be willing and able to swallow up to 4 tablets (pritelivir or matching placebo) and 1 capsule (over-encapsulated moxifloxacin or matching placebo) at least twice during the trial.
• Normal body weight as evidenced by a Body Mass Index (BMI) ≥18.0 and ≤25.0 kg/m2, and a body weight ≥50.0 kg at Screening.
• Subjects must have a negative test result for HIV-I- and -II-antibody, HBsAg, anti-hepatitis B core antigen (HBc) (IgG + IgM) and anti-hepatitis C virus (HCV) at Screening.
• Subjects had to have negative urine tests for drugs of abuse (benzodiazepines, opiates, amphetamines, methadone, cocaine, cannabinoids, barbiturates, cotinine) and negative breath alcohol tests at Screening and Admission for the in-house phase (Day -2).
• Normal triplicate 12-lead ECG measured after 10 minutes in the supine position at screening and on admission on Day -2 showing regular sinus rhythm with a well-defined end of T.
• Normal 24-hour 12-lead ECG at screening.

You may not qualify if:

• History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food.
• History of any moderate or severe allergy or any known allergy to any active or inactive ingredient(s) of moxifloxacin investigational medicinal product (IMP), pritelivir IMP, or their respective matching placebos.
• Any special dietary requirements that would have prevented the consumption of standardized meals.
• History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematologic, endocrine, metabolic, neurological, psychiatric, or other disease suspected to influence pharmacokinetics or safety of the IMP.
• History or any current evidence of a dermatological condition requiring treatment by a general practitioner (GP) or specialist (with the exception of burns, fungal infections, and/or warts).
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or may bias the result of the trial or the subject's ability to participate in the trial.
• History of malignancy.
• Has vital signs consistently outside of normal range at screening or Day -1. Acceptable normal range was as follows:
• supine heart rate (HR) 40 - 100 bpm (after at least five minutes of supine rest)
• supine blood pressure (after at least five minutes of supine rest):
• systolic blood pressure: 90 - 130 mmHg
• diastolic blood pressure: 40 - 90 mmHg
• The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise-related clinically significant cardiac events; known cardiovascular disease.
• Consistent abnormal interval readings for PR, QRS and QTc intervals (PR \<120ms or \>210ms, QRS \>120ms or QTcF \>450ms for males and \>470ms for females).
• Chronic or clinically relevant acute infections or febrile illness within 5 days prior to administration of the IMP.

Sponsors & Collaborators

• AiCuris Anti-infective Cures AG: lead

Study Sites (1)

Richmond Pharmacology Ltd

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Interventions

pritelivir; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Information Desk
• Organization: AiCuris Anti-infective Cures GmbH

info@aicuris.com

+4920231763

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 4, 2023
• Study Start: December 4, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Locations

GB (1)