HSV InfectionPhase 1NCT05513625
Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir
A Phase 1 study testing Pritelivir and ESO and pritelivir in people with HSV Infection, run by AiCuris Anti-infective Cures AG at 1 site in United States.
Trial summary
To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HSV Infection
- What is being tested?
- Pritelivir and ESO and pritelivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 13 Oct 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- Normal body weight as evidenced by a Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2, and a body weight ≥50.0 kg at Screening.
- Subjects had to have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), and human immunodeficiency virus (HIV) at Screening;
- Subjects had to have negative urine tests for drugs of abuse (metamphetamines, amphetamines, 3,4-Methylendioxyamphetamin (MDMA), barbiturates, benzodiazepines, cannabinoids, opioids, cocaine and tricyclic antidepressants) and negative breath alcohol tests at Screening and Admission in each Treatment Period.
Who cannot join
- 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
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- 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
- Consumption of alcohol and tobacco products within 48 hours prior to admission to the clinic until discharge of each period
- Vegetarian diet or other dietary habits which would have precluded the subject's acceptance of standardized meals
- Diseases or surgery of the gastrointestinal tract which may have interfered with drug absorption (note: this was not applicable for minor abdominal surgery such as eg, appendectomy and herniotomy)
- Receipt of any Investigational Medicinal Product (IMP) within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to trial drug administration.
- Blood donation or loss of 550 mL or more within the last 30 days before start of Screening (Pre-trial examination)
- Smoking of more than 10 cigarettes/cigars/pipes per Day and/or inability to refrain from smoking during confinement
- Intake of more than 12 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- Had any finding that, in the view of the Investigator, would have compromised the subject's safety requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
Official title: A Single-center, Open-label, 2-period Fixed-sequence Phase I Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Pritelivir
To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.
Read the detailed description
This was a single-center, open-label, 2-period, fixed-sequence Phase 1 trial in 16 healthy adult male and female subjects (at least 7 subjects per sex). In the first period, subjects received treatment 1 (T1; single dose of 100 mg PTV on Day 1). In the second period, subjects received treatment 2 (T2: 40 mg qd ESO from Day -3 to Day 1 followed by a single dose of 100 mg PTV on Day 1). The wash-out period between PTV administrations in T1 and T2 was at least 4 weeks.
- Conditions
- HSV Infection
- Being tested
- Pritelivir, ESO and pritelivir
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PritelivirDrug
oral administration
ESO and pritelivirDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| 100 mg pritelivir | Experimental | Single dose 100 mg pritelivir (PTV) administered day 1 Receives: 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 Receives: Drug: ESO and pritelivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK - Cmax
Cmax - the maximum observed plasma concentration
Measured: 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
Measured: 15 days
Secondary outcomes (5)
PK - Tmax and Tlag
tmax - time to reach the maximal observed analyte concentration and tlag - time period between the time of dosing and the time of the first measurable concentration
Measured: 15 days
PK - λz
λz - the apparent terminal elimination rate constant, determined by linear regression of terminal points of the ln-linear analyte concentration-time curve
Measured: 15 days
PK t1/2z
t1/2z - the apparent terminal elimination half-life calculated as: t1/2z = 0.693 / λz
Measured: 15 days
PK - CL/F
CL/F - total apparent clearance of drug following single dose e.v. administration calculated as: CL/F = Dose / AUC0-∞
Measured: 15 days
V d/F
V d/F - apparent volume of distribution after a single dose e.v. administration calculated as Vd/F = Dose e.v. / (λz * AUC0-∞)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start13 Jul 2020
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiCuris Anti-infective Cures AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513625
- Sponsor's protocol ID
- AIC316-03-I-01
- Status last verified
- Sep 2022
- First submitted
- 22 Aug 2022
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, 2-period Fixed-sequence Phase I Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Pritelivir
- ClinicalTrials.gov ID
- NCT05513625
- Acronym / sponsor ID
- AIC316-03-I-01
- Conditions
- HSV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AiCuris Anti-infective Cures AGIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 15 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.
Detailed description
This was a single-center, open-label, 2-period, fixed-sequence Phase 1 trial in 16 healthy adult male and female subjects (at least 7 subjects per sex). In the first period, subjects received treatment 1 (T1; single dose of 100 mg PTV on Day 1). In the second period, subjects received treatment 2 (T2: 40 mg qd ESO from Day -3 to Day 1 followed by a single dose of 100 mg PTV on Day 1). The wash-out period between PTV administrations in T1 and T2 was at least 4 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 100 mg pritelivir | Experimental | Drug: PritelivirSingle dose 100 mg pritelivir (PTV) administered day 1 |
| 40 mg qd ESO and 100 mg pritelivir | Experimental | Drug: ESO and pritelivir40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Priteliviroral administration | Drug | 100 mg pritelivir |
| ESO and priteliviroral administration | Drug | 40 mg qd ESO and 100 mg pritelivir |
Primary outcome
PK - Cmax
Time frame: 15 days
Cmax - the maximum observed plasma concentration
PK - AUC(0-infinity) and AUC(0-last)
Time frame: 15 days
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
5 secondary outcomes
PK - Tmax and Tlag
Time frame: 15 days
PK - λz
Time frame: 15 days
PK t1/2z
Time frame: 15 days
PK - CL/F
Time frame: 15 days
V d/F
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pritelivir and ESO and pritelivir in people with HSV Infection, run by AiCuris Anti-infective Cures AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK - Cmax (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.