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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445338
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : April 15, 2018
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : December 6, 2019

Arm Intervention/treatment
Experimental: Cohort 1 Drug: K0706
Study

Experimental: Cohort 2 Drug: K0706
Study

Experimental: Cohort 3 Drug: K0706
Study




Primary Outcome Measures :
  1. minimum concentration of study drug cerebrospinal fluid (CSF) [ Time Frame: Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445338


Locations
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United States, California
SPARC Site 1
Glendale, California, United States, 91206
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT03445338    
Other Study ID Numbers: CLR_17_06
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No