A Phase 1, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PRAX-114 in Healthy Subjects
Praxis Precision Medicines Australia Pty Ltd
48 participants
Jun 25, 2018
Interventional
Conditions
Summary
The study is a phase 1, double-blind, placebo-controlled, randomized study to evaluate the safety, tolerability, and pharmacokinetics of multiple-ascending doses of PRAX-114 in healthy subjects. In addition, potential metabolites of PRAX-114 will also be evaluated.
Eligibility
Inclusion Criteria6
- A participant must meet the following criteria at Screening (Days -28 to -2) to be eligible to participate in this study:
- The subject must be a female of nonchildbearing potential or male and between the ages of 18 and 55 years, inclusive. Documentation of hysterectomy, bilateral tubal ligation, or postmenopausal status must be available for female subjects.
- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- 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
- 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
- The subject must be willing to sign an informed consent document indicating that he/she understands the purpose of the study and the procedures that are required for the study and that he/she is willing to participate in the study.
Exclusion Criteria13
- A participant who meets any of the following criteria at Screening (unless otherwise specified) will be excluded from this study:
- 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
- Any abnormal electrocardiographic (ECG) findings at Screening judged to be clinically significant by the Investigator
- Any abnormal laboratory value or physical examination findings at Screening that is judged by the Investigator as clinically significant
- Hemoglobin less than 12 g/dL
- Serology test positive for HIV, or hepatitis B or C at Screening
- Positive drug test for ethanol, barbiturates, cocaine, methamphetamines, Methadone, benzodiazepines, phencyclidine, tetrahydrocannabinols, methylenedioxymethamphetamine, opiates, or amphetamines at Screening and clinic Check-in
- Smokers and/or Positive urine cotinine test at Screening and Check-in
- Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplements 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
- 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
- Donation or loss of great than or equal to 400 mL blood within 8 weeks and/or donation of plasma within 7 days prior to initial dosing of study drug
- History of drug or alcohol abuse within 12 months prior to initial dosing of study drug. Abuse is defined as consumption of greater than 2 standard drinks per day (14 standard drinks per week)
- Psychosocial or addictive disorders that would interfere with subject’s ability to give informed consent or could compromise compliance with the protocol
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Interventions
This study will be performed in healthy male and female subjects with administration of multiple oral doses of PRAX-114 or vehicle (placebo) in suspension for 14 days in a sequential ascending manner. Subjects will be fasted overnight (no food or drink except water) for at least 8 hours prior to dosing. Up to 48 healthy male and female subjects will be enrolled. Within each cohort, the subjects will be randomized in a 3:1 ratio with 9 subjects in the active group and 3 subjects in the placebo group. Eligible subjects will be assigned to 1 of 4 cohorts and will receive 1 or 2 daily doses of study treatment for 14 days with doses ranging from 15 mg to 60 mg daily. Cohort 1: 15 mg once a day Cohort 2: 30 mg once a day Cohort 3: 60 mg once a day Cohort 4: 30 mg two times per day These multiple dose cohorts will be followed by a single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover evaluation of food effects at 30mg (once fasted once fed). Adherence to the intervention will be monitored by direct observation by study personnel at the clinical trials site.
Locations(1)
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ACTRN12618000650291