To Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:3/20/2019
Start Date:April 15, 2018
End Date:June 2019
Contact:Sun Pharma Advanced Research Company Limited
Email:clinical.trials@sparcmail.com
Phone:91226645 5645

Use our guide to learn which trials are right for you!

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

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


Inclusion Criteria:

1. Healthy adult male subjects, 18 to 45 years of age, inclusive, at screening.

2. Willing and able to give written, and dated an informed consent.

3. 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.

4. Medically healthy on the basis of medical history and physical examination.

5. 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.

Exclusion Criteria:

1. Subjects with a history of a frequent headache, nausea, or vomiting suggestive of
increased intracranial pressure.

2. 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;

3. Subjects with a history of any relevant allergy/hypersensitivity.

4. Subjects determined by the investigator to have any medical condition that could
jeopardize their health or prejudice the results.

5. Subjects who have participated in CSF collection studies within 56 days prior to
check-in.

6. Subjects who donated plasma within 14 days prior to the check-in visit.
We found this trial at
1
site
685 Venice Boulevard
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials