A Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers

Sun Pharma Advanced Research Company Limited1 site in 1 country18 target enrollmentApril 15, 2018

ConditionsHealthy

InterventionsK0706

Overview

Phase: Phase 1
Intervention: K0706
Conditions: Healthy
Sponsor: Sun Pharma Advanced Research Company Limited
Enrollment: 18
Locations: 1
Primary Endpoint: minimum concentration of study drug cerebrospinal fluid (CSF)
Status: Completed
Last Updated: 6 years ago

This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of K0706 in healthy adult male subjects.

Registry

clinicaltrials.gov

Start Date

April 15, 2018

End Date

December 6, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Sponsor

Responsible Party

Sponsor

•Healthy adult male subjects, 18 to 45 years of age, inclusive, at screening.
•Willing and able to give written, and dated an informed consent.
•Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions in the Investigator's opinion, and be accessible for follow-up.
•Medically healthy on the basis of medical history and physical examination.
•Subjects enrolled in the study should not father a child and follow the necessary precautionary measure to be taken during the course of the study.

•Subjects with a history of a frequent headache, nausea, or vomiting suggestive of increased intracranial pressure.
•Subject report of recent (6-month) alcohol abuse or illicit drug use or who tests positive at screening, Check-in, or outpatient Visits for breath alcohol and/or drugs of abuse or cotinine;
•Subjects with a history of any relevant allergy/hypersensitivity.
•Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results.
•Subjects who have participated in CSF collection studies within 56 days prior to check-in.
•Subjects who donated plasma within 14 days prior to the check-in visit.