Skip to main content
OpenTrials
Completed

NCT Number: NCT03445338

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 1

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

K0706

Drug

Study

Primary outcomes

  1. minimum concentration of study drug cerebrospinal fluid (CSF)

    Time frame: Day 8

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study title

A Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.