A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of VGT-309 in Healthy Subjects
- Conditions
- CancerCancer - Any cancer
- Registration Number
- ACTRN12620000948998
- Lead Sponsor
- Vergent Bioscience Australia, Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
1. Be willing and able to sign the informed consent and comply with study procedures.
2. Be between the ages of 18 and 55, inclusive
3. Be male or female and meet the following conditions:
a. Female participants must be of non-childbearing potential, or,
b. If of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception.
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.
d. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
- Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
- Intrauterine device or intrauterine hormone-releasing system
NOTE: Participants that are abstinent from heterosexual intercourse as part of their usual and preferred lifestyle are not required to use contraception
4. Be considered healthy by the Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs
5. Be a nonsmoker, defined as not having smoked, vaped or used any form of tobacco for more than 6 months before screening. NOTE: subjects who smoke occasionally (no more than 2 cigarettes per week) are allowed provided their cotinine test is negative at screening and they abstain from smoking during the study.
6. Be willing to stop all prescription or over-the-counter medications from 7 days prior to admission to Day 7 of the study.
7. Not have participated in a clinical trial within the last 30 days
1. A positive blood screen for human immunodeficiency virus (HIV) antibodies, hepatitis B surface or core antigen (HBsAg, HBcAg), or hepatitis C antigen
2. A hospital admission or major surgery within 30 days prior to screening
3. A pre-planned hospital admission or surgery scheduled within 30 days post-dosing
4. A known allergy or reaction to ICG or other radiographic contrast agents
5. A history of prescription drug abuse or illicit drug use within 6 months prior to screening
6. A history of alcohol abuse within 6 months prior to screening as determined by the PI
7. A positive screen for alcohol or drugs of abuse including cotinine
8. Donated more than one unit of blood or blood products during the 3 months prior to screening
9. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study
10. A history of clinically significant hypotension
11. Abnormal systolic or diastolic blood pressure or heart rate at screening or Day -1
12. Congenital long QT or QTcF>450 ms (males) or >470 ms (females) by history or at screening
13. AST, ALT or bilirubin > upper limit of normal at screening
14. Serum creatinine > upper limit of normal at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method