To Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy
In brief
This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of K0706 in healthy adult male subjects.
Key facts
- Study ID
- NCT03445338
- Run by
- Sun Pharma Advanced Research Company Limited
- People needed
- 18
- Starts
- 2018-04-15
- Expected to finish
- 2019-12-06
- Last updated by the study team
- 2020-01-14
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- SPARC Site 1 — Glendale, California, United States
Full record on ClinicalTrials.gov
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