NCT03316820

Brief Summary

This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

October 28, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2017

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

24 days

First QC Date

October 17, 2017

Last Update Submit

May 2, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Observed peak plasma concentration

    72 hours

Secondary Outcomes (1)

  • Adverse event

    26 days

Study Arms (4)

Treatment A

EXPERIMENTAL

K0706 tablet

Drug: K0706

Treatment B

EXPERIMENTAL

K0706 tablet

Drug: K0706

Treatment C

EXPERIMENTAL

K0706 tablet

Drug: K0706

Treatment D

EXPERIMENTAL

K0706 capsule

Drug: K0706

Interventions

K0706DRUG

Study treatment with water after an overnight fast

Treatment ATreatment BTreatment CTreatment D

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
  • Adult males or females aged between 18 and 55 years
  • Medically healthy on the basis of medical history and physical examination
  • Woman of childbearing potential must practice an acceptable method of birth control

You may not qualify if:

  • History of any major surgical or medical conditions within 4 weeks prior to dosing
  • History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
  • Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
  • Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC Site 1

Las Vegas, Nevada, 89121, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 20, 2017

Study Start

October 28, 2017

Primary Completion

November 21, 2017

Study Completion

November 21, 2017

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)