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 |
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.
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.
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