None listed
Conditions
Brief summary
A healthy volunteer study testing a new drug, CNT2130. This study will assess the safety, tolerability, and PK of different doses of CNT2130 after single oral administrations.
Interventions
CNT2130 is an oral capsule that will be administered in 3 groups. Group 1 will administer a dose of 15 milligrams (mg). Group 2 will administer a dose of 45 mg, and Group 3 will administer a dose of 90 mg. A single dose will be administered once in each group by the research staff. The research staff will perform a mouth check after dosing for compliance.
Sponsors
Centaurus Therapeutics Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females ages 18 to 55 years old, inclusive, at screening. 2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening. 3. Weight greater than or equal to 50 kg for males and greater than or equal to 45 kg for females. 4. Ability and willingness to abstain from alcohol from 24 hours prior to admission to the clinical research center through discharge. 5. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator
Exclusion criteria
1. History of any clinically significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease, malignancies, significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), immunosuppressive conditions or medications, recent or recurrent infections, or any other clinically significant disease, as assessed by the Investigator. Basal cell or squamous cell carcinoma of the skin that has been fully excised and is considered cured is acceptable. 2. Any history of alcohol abuse or drug addiction (including cannabis products) as defined by local guidance. 3. Positive drug screen (cannabinoids (marijuana), amphetamines, methamphetamines, opiates, methadone, cocaine, benzodiazepines, barbiturates, 3,4-methylenedioxymethamphetamine (MDMA), phencyclidine, and tricyclic antidepressants). 4. Average intake of > 14 units of alcohol per week for females and > 21 units of alcohol per week for males (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 5. Unwillingness to refrain from strenuous exercise within 96 hours (4 days) prior to admission. 6. Positive for hepatitis B surface antigen (HbsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies. 7. Participation in any investigational drug study within 30 days of Day 1, or within 5 half-lives of the drug (whichever is longer), or have participated in more than 4 investigational drug studies within 12 months of screening. 8. Donation or loss of more than 500 mL of blood or blood products within 60 days of screening, or plasma donations in the last 30 days prior to screening. 9. Received a live vaccine within 4 weeks prior to screening. 10. Any other medical condition or social circumstance, which in the opinion of the Investigator, would impede compliance with or hinder completion of the study
Outcome results
None listed