A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GRX-917 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of GRX-917 in Healthy Adult Subjects
Gaba Therapeutics Australia Pty Ltd a subsidiary of Gaba Therapeutics, Inc
76 participants
Jun 3, 2021
Interventional
Conditions
Summary
This project is testing the safety and pharmacokinetics and pharmacodynamics of single and multiple oral doses of a new drug called GRX-917. GRX-917 has the potential to treat depression and anxiety. Who is it for? You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. Study details Participants will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of either the active study drug or placebo. Total participation will last between 11 days and 25 days which will include a screening period and between 3 days (2 nights) and 9 days (8 nights) in the clinic during which we will need to collect blood and urine samples. It is hoped that this research will help determine the safety of GRX-917 when given to healthy men or women so that it can be tested in patients with depression.
Eligibility
Inclusion Criteria15
- Aged between 18 and 55 years of age at time of consent
- 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 from screening through 30 days post- dose. Hormonal forms of contraception are contraindicated in this study.
- c. Male participants, 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.
- 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.
- Weigh at least 50 kg at the time of screening
- Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 at the time of screening
- Negative SARS-CoV2 test on Day -2 per site standards
- Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
- Willing to refrain from will refrain from any systemic or topical medication, including herbal supplements taken within 6 times the elimination half-life of the medication or within 14 days of the first dose administration, whichever is longer.
- Willing and able to refrain from consuming any strong inhibitors or inducers of CYP3A4 and CYP2B6 within 30 days prior to dosing
- Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug
- 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.
- Willing and able to provide written informed consent
Exclusion Criteria15
- History of seizures, convulsions or increased intra-cranial pressure with the exception of pediatric febrile seizures
- History of moderate or severe psychiatric illness
- 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, bradycardia, or tachycardia.
- Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the PI or designee at screening
- Has clinically significant laboratory abnormalities
- History of moderate or severe substance abuse within 5 years prior to screening
- History of alcohol abuse within 5 years prior to screening
- Positive alcohol breath test or urine test for drugs of abuse
- 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
- 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.
- Has taken a Serotonin-Norepinephrine Reuptake Inhibitors or Selective Serotonin Reuptake Inhibitor or benzodiazepine within 30 days prior to dosing.
- Prior use of a 5-alpha reductase inhibitor within 3 months prior to dosing.
- 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
- Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition 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.
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Interventions
Approximately 76 healthy men or women will be enrolled in this study. There will be two parts to the study. In the first part of the study approximately 40 healthy men and women will be enrolled in up to 5 single ascending dose cohorts comprising 8 subjects each. Subjects within each cohort will be randomised to receive a single dose of either oral GRX-917 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct observation in the Phase 1 unit. The doses for each cohort are shown below Cohort 1: 25mg Cohort 2: 50mg Cohort 3: 100mg Cohort 4: 250mg Cohort 5: 500mg In the second part of the study approximately 36 healthy men and women will be enrolled into up to 3 multiple ascending dose cohorts comprising 12 subjects each. Subjects within each cohort will be randomised to receive multiple doses of either oral GRX-917 (9 subjects) or oral placebo (3 subjects). Each dose regimen will be administered for 7 days (13 total doses); dosing every 12 hours on Day 1 through Day 6 with a single last dose given on Day 7. All doses will be administered under direct observation in the Phase 1 unit. The doses for each cohort are shown below Cohort 1: 100mg every 12 hours Cohort 2: 200mg every 12 hours Cohort 3: 300mg every 12 hours
Locations(1)
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ACTRN12621000160831