Healthy
Conditions
Brief summary
This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of K0706 in healthy adult male subjects.
Interventions
DRUGK0706
Study
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| minimum concentration of study drug cerebrospinal fluid (CSF) | Day 8 |
Countries
United States
Outcome results
None listed