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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-12-06

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

K0706

Intervention Type DRUG

Study

Cohort 2

Group Type EXPERIMENTAL

K0706

Intervention Type DRUG

Study

Cohort 3

Group Type EXPERIMENTAL

K0706

Intervention Type DRUG

Study

Interventions

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K0706

Study

Intervention Type DRUG

K0706

Study

Intervention Type DRUG

K0706

Study

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes