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

NCT03445338 | Completed Phase 1 FDA Drug

• 1 other identifier: CLR_17_06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• minimum concentration of study drug cerebrospinal fluid (CSF)

  Day 8

Study Arms (3)

Cohort 1

EXPERIMENTAL

Drug: K0706

Cohort 2

EXPERIMENTAL

Drug: K0706

Cohort 3

EXPERIMENTAL

Drug: K0706

Interventions

K0706 DRUG

Study

Cohort 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (1)

SPARC Site 1

Glendale, California, 91206, United States

Location

Related Publications (1)

• Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.

  PMID: 40680102 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: April 15, 2018
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)