None listed
Conditions
Brief summary
The study is a Phase 1, double-blind, randomized, placebo-controlled, first in human study of PRAX-330 to assess the safety, tolerability and pharmacokinetics of single ascending oral doses in healthy subjects.
Interventions
This study will be performed in healthy male subjects with administration of a single oral dose of PRAX-330 or vehicle (placebo) in solution in a sequential ascending manner. In Cohorts 1 through 7 subjects will be fasted overnight (no food or drink except water) for 10 hours prior to dosing.
Up to 56 healthy male subjects will be enrolled. Within each cohort, the subjects will be randomized in a 3:1 ratio with 6 subjects in the active group and 2 subjects in the placebo group.
Eligible subj
This study will be performed in healthy male subjects with administration of a single oral dose of PRAX-330 or vehicle (placebo) in solution in a sequential ascending manner. In Cohorts 1 through 7 subjects will be fasted overnight (no food or drink except water) for 10 hours prior to dosing. Up to 56 healthy male subjects will be enrolled. Within each cohort, the subjects will be randomized in a 3:1 ratio with 6 subjects in the active group and 2 subjects in the placebo group. Eligible subjects will receive study treatment with a starting dose of 0.1 mg dose escalated up to 15 mg.
Sponsors
Praxis Precision Medicines Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects between ages 18-50 years (inclusive) at time of Screening 2. Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive) 3. Resting supine vital signs at Screening within the following ranges: - Systolic blood pressure (SBP) 90 to 140 mmHg - Diastolic blood pressure (DBP) 40 to 90 mmHg - Heart rate (HR) 40 to 100 beats per minute 4. Male subjects with female partners of childbearing potential must be using 2 acceptable methods of contraception, including at least one barrier method, from the day of first dose of study drug to at least 90 days after the last dose of study drug. Periodic abstinence and withdrawal are not acceptable methods of contraception 5. Willing and able to comply with the requirements of the protocol and directions from the clinic staff 6. Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges within 2 weeks prior to first dose of study drug until discharge from the clinic 7. Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages within 2 weeks prior to first dose of study drug until discharge from the clinic 8. Understand and willing to sign informed consent
Exclusion criteria
1. Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug 2. Any abnormal electrocardiographic (ECG) findings at Screening judged to be clinically significant by the Investigator 3. Any abnormal laboratory value or physical examination findings at Screening that is judged by the Investigator as clinically significant 4. Hemoglobin <12 g/dL 5. Serology test positive for HIV, or hepatitis B or C at Screening. 6. Positive drug test for ethanol, barbiturates, cocaine, methamphetamines, Methadone, benzodiazepines, phencyclidine, tetrahydrocannabinols, methylenedioxymethamphetamine, opiates, or amphetamines at Screening and clinic Check-in 7. Positive urine cotinine test at Screening and Check-in 8. Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks or 5 times the terminal half-lives of the medication prior to first dose of study drug, whichever is longer and for the duration of the study. 9. Use of any experimental or investigational drug or device within 30 days prior to first dose of study drug or 5 half-lives of the drug, whichever is longer 10. Donation or loss of =400 mL blood within 8 weeks and/or donation of plasma within 7 days prior to initial dosing of study drug 11. History of drug or alcohol abuse within 12 months prior to initial dosing of study drug 12. Psychosocial or addictive disorders that would interfere with subject’s ability to give informed consent or could compromise compliance with the protocol
Outcome results
None listed