None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of both single and multiple oral doses of an already approved drug called etifoxine. This study will run in 2 stages and involve approximately 30 participants in total. Stage 1 will evaluate the pharmacokinetics, pharmacodynamics and safety of single doses of etifoxine. This stage will enrol approximately 12 participants into a crossover design study where they will receive either etifoxine as a single dose or a placebo at the first visit and then they will receive the opposite intervention at the next visit 7 days later. Stage 2 will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of etifoxine. This stage will enrol approximately 18 participants who will be randomised to receive either etifoxine or a placebo given every 12 hours for 7 days.
Interventions
Stage 1: Etifoxine 100mg single oral dose (2 x 50mg capsules). This is an active to placebo crossover design. Subjects will receive the single oral dose of either etifoxine or placebo on Day 1 and then receive a single oral dose of the alternate treatment on Day 7. Subjects will receive all medication in the clinic
Stage 2: Etifoxine 100mg oral dose (2 x 50mg capsules) every 12 hours for 7 days. Participants will use a subject diary to ensure compliance with the medication regimen.
Partic
Stage 1: Etifoxine 100mg single oral dose (2 x 50mg capsules). This is an active to placebo crossover design. Subjects will receive the single oral dose of either etifoxine or placebo on Day 1 and then receive a single oral dose of the alternate treatment on Day 7. Subjects will receive all medication in the clinic Stage 2: Etifoxine 100mg oral dose (2 x 50mg capsules) every 12 hours for 7 days. Participants will use a subject diary to ensure compliance with the medication regimen. Participants in Stage 2 are different to those in Stage 1. The decision to proceed to Stage 2 will be based on the safety in Stage 1
Sponsors
Gaba Therapeutics Australia Pty Ltd a subsidiary of Gaba Therapeutics, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males aged between 18 and 65 years of age at time of consent 2. Agrees to and comply with using single barrier method of birth control or sexual abstinence, and not donate sperm, for the duration of the study and for 90 days after last dose of study drug. 3. 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. 4. Has a body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2 5. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments 6. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose through the EOS assessments, except for acetyl-para-aminophenol or in the case of necessary treatment of adverse events 7. Willing to refrain from alcohol from 48 hours before first dose through the last dose of study drug 8. 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. 9. Willing and able to provide written informed consent
Exclusion criteria
1. Known allergy or hypersensitivity to etifoxine or any of the excipients of etifoxine. 2. Has congenital galactosemia, glucose and galactose malabsorption syndrome or is lactose intolerant 3. History of seizures, convulsions or increased intra-cranial pressure with the exception of pediatric febrile seizures 4. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening 5. 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. Clinically significant screening values measured after 5 minutes of rest in a supine position include: a. Abnormal systolic blood pressure (<90 or > 140 mmHg) b. Abnormal diastolic blood pressure (<40 or > 90 mmHg) c. Abnormal respiratory rate (<10 or > 22 bpm) 6. 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 <50bpm or > 100 bpm); b. Average QT interval corrected using Fridericia’s formula (QTcF) interval duration > 450 msec; c. Average QRS interval > 120 msec after being confirmed by manual over-read d. Average PR interval > 220 msec 7. Has clinically significant laboratory abnormalities including: a. Impaired renal function (serum creatinine levels >106 µmol/L) at screening. b. ALT or AST laboratory values >1.2X upper normal limits. c. Subject has an estimated creatinine clearance of <80 mL/min as determined by the Cockcroft-Gault equation 8. History of moderate or severe substance abuse defined by the DSM-V criteria within 5 years prior to screening 9. 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 10. Positive alcohol breath test or urine test for drugs of abuse 11. Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibody, and anti-human immunodeficiency virus (HIV) type 1 antibody 12. 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. 13. Has taken a Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) or Selective Serotonin Reuptake Inhibitor (SSRI) within 30 days prior to dosing. 14. Prior use of a 5-alpha reductase inhibitor (e.g., finasteride or dutasteride). 15. Has donated blood or plasma within 30 days prior to screening, or had a loss of whole blood of more than 50 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening 16. Has experienced symptoms of acute illness or chronic disease within 15 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 17. Is from a vulnerable population as defined by ICH Guideline for GCP E6 (R2), including but not limited to, employees or family member of the research staff conducting the study, or of the Sponsor, or of the CRO, or the HREC 18. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements 19. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the subject unsuitable for enrollment.
Outcome results
None listed