A study to compare the pharmacokinetics and pharmacodynamics of the free base form of PRTX007, the hydrochloride salt form of PRTX007 and the hydrochloride salt form of PRTX007 in combination with probenecid in healthy adults
- Conditions
- COVID-19Infection - Other infectious diseasesRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12623000468628
- Lead Sponsor
- Primmune Therapeutics Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
1. Male or female and meet the following conditions:
a. Female participants must be of non-childbearing potential, defined as absence of menses for at least 1 year prior to dosing (without an alternative medical condition); and FSH levels less than or equal to 40 mIU/mL at screening; or,
b. If of childbearing potential, be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days post dose.
c. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post dose and agree not to donate sperm during this period.
d. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
i. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
ii. Intrauterine device or intrauterine hormone-releasing system
e. Participants who do not engage in heterosexual intercourse will be considered abstinent and do not require contraception. Abstinence must be an ongoing and usual lifestyle of
the participant and complete abstinence must be maintained from screening through 30 days post dose.
2. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug.
3. Weigh at least 45kg at the time of screening
4. Have a body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2 at the time of screening
5. Negative SARS-CoV2 test per site standards
6. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
7. Willing to refrain from over-the-counter (OTC) or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose through the final follow-up visit, except for limited use of acetyl-para-aminophenol (APAP) or in the case of necessary treatment of adverse events (AEs). Limited use of APAP is defined as less than 3g/day. These limits do not apply to its use for the necessary medical treatment of adverse events.
8. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug
9. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking during the confinement period.
10. Willing and able to provide written informed consent
1. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening
History of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, or tachycardia. Clinically significant screening values measured after 5 minutes of rest in a supine position include:
a. Abnormal systolic blood pressure (<90 or > 150 mmHg)
b. Abnormal diastolic blood pressure (<40 or > 95 mmHg)
c. Abnormal respiratory rate (<10 or > 22 bpm)
3. Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the PI or designee at screening, including:
a. Abnormal sinus rhythm (heart rate <40 bpm or > 100 bpm);
b. Average QT interval corrected using Fridericia’s formula (QTcF) interval duration >
450 msec for males and > 470 msec for females;
c. Average QRS interval > 120 msec after being confirmed by manual over-read
d. Average PR interval > 220 msec
4. Has clinically significant laboratory abnormalities including:
a. Impaired renal function (serum creatinine levels >106 µmol/L) at screening.
b. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) laboratory
values >1.5X upper normal limits.
c. Subject has an estimated creatinine clearance of <80 mL/min as determined by the
Cockcroft-Gault equation
Laboratory screening can be repeated upon investigator discretion.
5. History of prescription drug abuse or illicit drug use within 6 months prior to screening
6. History of moderate or severe psychiatric illness, based on physician’s judgement
7. History of alcohol abuse defined as an average daily intake >3 units, or an average weekly intake >21 units, where 1 unit is equivalent to 1 can or bottle (355mL) of beer, or 1 measure (25mL) of spirits, or 1 glass (175 mL) of wine within 5 years prior to screening
8. Positive alcohol breath test or urine test for drugs of abuse
9. Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antigen, and anti-human immunodeficiency virus (HIV) type 1 antibody
10. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable. Receipt of the COVID-19 vaccine will be allowed up to 14 days prior to the first dose of study drug. Subjects will not be allowed to receive the COVID-19 vaccine from 14 days prior to the first dose through to 7 days after the last dose of study drug.
11. Has prior exposure to PRTX007
12. Has donated blood or plasma within 30 days prior to screening, or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening
13. Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition (medical or surgical) that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the subject at risk as a result of participation in the study
14. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method