Clinical Trial: Bioavailability, Safety, and Tolerability of BIS-001 ER

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects

Brief Summary: This study investigates the safety, tolerability, and pharmacokinetics of BIS-001 ER in healthy volunteers. Subjects will be dosed twice daily, with a dose escalation occurring every 2-3 days until a maximum dose of 5mg per day is reached.

Detailed Summary:
Sponsor: Biscayne Neurotherapeutics, Inc.

Current Primary Outcome:

• Maximum serum concentration; Cmax [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Area under the curve; AUC [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Time of maximum serum concentration; Tmax [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Half-life; t1/2 [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Terminal elimination [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Clearance [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Volume of distribution [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments
• Mean residence time [ Time Frame: 16 Weeks ]
  Bioavailability/Pharmacokinetic Assessments

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Safety and Tolerability Assessments - Adverse Events [ Time Frame: 16 Weeks ]
  Adverse events will be defined, documented, evaluated (mild/moderate/severe/life threatening; serious/non-serious; expected/unexpected; causally related to study drug or not) and reported according to all applicable institutional and governmental requirements and guidance.
• Safety and Tolerability Assessments - Vital Signs [ Time Frame: 16 Weeks ]
  Vital signs (e.g. blood pressure) will be monitored through the first 8 hrs after drug administration, as well as at Baseline and pre-dose.
• Safety and Tolerability Assessments - Neurological Evaluation [ Time Frame: 16 Weeks ]
  A standard neurological examination will be performed according to the study-specific timeline. Clinically significant new or worsened abnormalities as compared to baseline findings will have to be reported as AEs.
• Safety and Tolerability Assessments - Physical Evaluation [ Time Frame: 16 Weeks ]
  A standard physical examination will be performed according to the study-specific timeline. Clinically significant new or worsened abnormalities as compared to baseline findings will have to be reported as AEs.
• Safety and Tolerability Assessments - ECG Evaluation [ Time Frame: 16 Weeks ]

  A standard 12-lead ECG in a supine position after a 5-minute rest will be performed according to the study-specific timeline.

  The Investigator will determine whether the results of the ECG are normal or abnormal and assess the clinical significance of any abnormality. ECG tracings will be reviewed by a cardiologist if required.

• Safety and Tolerability Assessments - Clinical Laboratory Studies: Hematology [ Time Frame: 16 Weeks ]
  Laboratory assessments will be conducted using standard methods.
• Safety and Tolerability Assessments - Clinical Laboratory Studies: Biochemistry [ Time Frame: 16 Weeks ]
  Laboratory assessments will be conducted using standard methods.
• Safety and Tolerability Assessments - Clinical Laboratory Studies: Urinalysis [ Time Frame: 16 Weeks ]
  Laboratory assessments will be conducted using standard methods.

Original Secondary Outcome: Same as current

Information By: Biscayne Neurotherapeutics, Inc.

Dates:
Date Received: May 15, 2017
Date Started: May 22, 2017
Date Completion: August 18, 2017
Last Updated: May 15, 2017
Last Verified: May 2017