- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513625
Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir
A Single-center, Open-label, 2-period Fixed-sequence Phase I Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Pritelivir
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45227
- Medpace CLinical Pharmacology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100 mg pritelivir
Single dose 100 mg pritelivir (PTV) administered day 1
|
oral administration
|
Experimental: 40 mg qd ESO and 100 mg pritelivir
40 mg qd ESO Day -3 to Day1.
Single dose of 100 mg PTV on Day 1
|
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK - Cmax
Time Frame: 15 days
|
Cmax - the maximum observed plasma concentration
|
15 days
|
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 |
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK - λz
Time Frame: 15 days
|
λz - the apparent terminal elimination rate constant, determined by linear regression of terminal points of the ln-linear analyte concentration-time curve
|
15 days
|
PK t1/2z
Time Frame: 15 days
|
t1/2z - the apparent terminal elimination half-life calculated as: t1/2z = 0.693 / λz
|
15 days
|
PK - CL/F
Time Frame: 15 days
|
CL/F - total apparent clearance of drug following single dose e.v.
administration calculated as: CL/F = Dose / AUC0-∞
|
15 days
|
V d/F
Time Frame: 15 days
|
V d/F - apparent volume of distribution after a single dose e.v.
administration calculated as Vd/F = Dose e.v.
/ (λz * AUC0-∞)
|
15 days
|
PK - Tmax and Tlag
Time Frame: 15 days
|
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
|
15 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIC316-03-I-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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