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

• Sponsor: Sun Pharma Advanced Research Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03445338
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Actual Duration (Months): 19.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: K0706; Drug: K0706; Drug: K0706	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
• Actual Study Start Date: Apr 15, 2018
• Actual Primary Completion Date: Dec 6, 2019
• Actual Study Completion Date: Dec 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1	Drug: K0706; Study
Experimental: Cohort 2	Drug: K0706; Study
Experimental: Cohort 3	Drug: K0706; Study

Outcome Measures

Primary Outcome Measures

1. minimum concentration of study drug cerebrospinal fluid (CSF) [Day 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPARC Site 1	Glendale	California	United States	91206

Sponsors and Collaborators

• Sun Pharma Advanced Research Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Pharma Advanced Research Company Limited
• ClinicalTrials.gov Identifier: NCT03445338
• Other Study ID Numbers: CLR_17_06
• First Posted: Feb 26, 2018
• Last Update Posted: Jan 14, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 14, 2020