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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: K0706

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • SPARC Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
minimum concentration of study drug cerebrospinal fluid (CSF)	Day 8

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CLR_17_06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No