Status:
COMPLETED
To Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of K0706 in healthy adult male subjects.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03445338
Start Date
April 15 2018
End Date
December 6 2019
Last Update
January 14 2020
Active Locations (1)
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1
SPARC Site 1
Glendale, California, United States, 91206