Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir

NCT05513625 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AIC316-03-I-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.

Conditions

HSV Infection

Outcome Measures

Primary Outcomes (2)

• PK - Cmax

  Cmax - the maximum observed plasma concentration

  15 days

• PK - AUC(0-infinity) and AUC(0-last)

  AUC0-∞ - area under the analyte vs time concentration curve from time of administration up to infinity, calculated as AUC0-∞ = AUC0-last + (Clast / λz) AUC0-last - area under the analyte vs. time concentration curve from time of administration up to the time of the last quantifiable concentration, calculated by linear up/ln down summation

  15 days

Secondary Outcomes (5)

• PK - Tmax and Tlag

  15 days

• PK - λz

  15 days

• PK t1/2z

  15 days

• PK - CL/F

  15 days

• V d/F

  15 days

Study Arms (2)

100 mg pritelivir

EXPERIMENTAL

Single dose 100 mg pritelivir (PTV) administered day 1

Drug: Pritelivir

40 mg qd ESO and 100 mg pritelivir

EXPERIMENTAL

40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1

Drug: ESO and pritelivir

Interventions

Pritelivir DRUG

oral administration

100 mg pritelivir

ESO and pritelivir DRUG

oral administration

40 mg qd ESO and 100 mg pritelivir

Eligibility Criteria

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

You may qualify if:

• Subjects had to have the ability to understand and sign written informed consent, which had to be obtained prior to any trial-related procedures being completed;
• Healthy male and female subjects of any ethnic origin, aged between 18 and 45 years (inclusive) assessed as healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, electrocardiogram (ECG) assessment, and clinical laboratory results.
• Female subjects of non-childbearing potential had to be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at Screening based on the central laboratory's ranges.
• Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) and all male subjects had to use a medically accepted contraceptive regimen during their participation in the trial and for 90 days after the last administration of trial drug. Medically accepted contraceptive methods were defined as those with 90% or greater efficacy.
• Acceptable methods of contraception for male subjects enrolled in the trial included the following:
• Condoms with spermicide.
• Surgical sterilization of the subject at least 26 weeks prior to Screening (vasectomy).
• Acceptable methods of contraception for female subjects enrolled in the trial included the following, (the subject had to choose two of the following \[a single barrier method alone or abstinence alone was not acceptable\]):
• Condoms with spermicide.
• Intrauterine device for at least 12 weeks prior to Screening.
• Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks prior to Screening.
• Diaphragm used in combination with spermicide.
• Male subjects had to agree to abstain from sperm donation and not plan to father a child (including sperm donation) through 90 days after administration of the last dose of trial drug.
• In women: a negative serum beta-human chorionic gonadotropin (β-HCG) test at Screening and negative urine β-HCG test at Admission in each Treatment Period.
• Subject agreed to pharmacogenetic blood sampling.

You may not qualify if:

• History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
• History of allergic reactions to any active or inactive ingredient(s) of the trial medication(s)
• History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease suspected to influence pharmacokinetics or safety of PTV
• History of malignancy
• Resting pulse rate after 5 minutes in supine position at Screening and Day -1 of Treatment Period 1: \<45 or \>100 beats per minute (bpm), if out of range, up to one repeat assessment was allowed
• Resting blood pressure after 5 minutes in supine position at Screening and Day -1 of Treatment Period 1: systolic blood pressure \<90 or \>145 mmHg diastolic blood pressure \<40 or \>95 mmHg, if out of range, up to one repeat assessment was allowed
• ECG abnormalities of clinical relevance (eg, QTc according to Fridericia: QTc \>450 ms in males and \>470 ms in females; PR ≥220 ms)
• Febrile or infectious illness within 5 days prior to administration of Investigational Medicinal Product
• Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
• Chronic or clinically relevant acute infections
• Diagnosed to be COVID-19 positive by polymerase chain reaction (PCR) testing (SARS-CoV-2 RT-PCR positive) of a respiratory specimen (preferably a nasopharyngeal swab) on Day -2 of Treatment Period 1
• Subject was lactating or breastfeeding
• Use of any medication (incl. over-the-counter \[OTC\] medication) within 2 weeks before first drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods. Use of hormonal contraceptives was allowed. Single intake of a drug may have been accepted if judged by the Investigators to have no clinical relevance and no relevance for the trial objectives. Limited amounts of acetaminophen were allowed to treat painful intercurrent adverse events (eg, headache, migraine).
• Consumption of any (eg, CYP1A2, CYP3A4) enzyme inducing or inhibiting aliments and beverages (eg, but not limited to broccoli, Brussels sprout, grapefruit, grapefruit juice, Seville orange, star fruit, tonic water, bitter lemon etc.) within 2 weeks prior to the Screening (Pre-trial examination)
• Consumption of methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks") from 24 hours before PTV dosing on Day 1 until release from the clinic on Day 5 of each period

Sponsors & Collaborators

• AiCuris Anti-infective Cures AG: lead

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

pritelivir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

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

info@aicuris.com

+4920231763

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequence for all subjects: Treatment 1: single dose of 100 mg PTV followed by Wash out period (4weeks) followed by Treatment 2: single dose of 100 mg PTV Day 1 and 40 mg/day ESO from Day -3 to Day 1

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: July 13, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: February 22, 2024
• Results First Posted: September 15, 2023

Record last verified: 2022-09

Locations

US (1)