Evaluation of Absorption, Metabolism, and Excretion and E... | NCT02676830

Studies
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312

NCT02676830

Sponsor

Kowa Research Institute, Inc.

Status

Completed

Last Update Posted

Feb 18, 2016Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Dyslipidemia

Interventions

K-312 100 mg
K-312 100 ug C14 IV

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Feb 2, 2016

First Submission Date that Met QC Criteria

Feb 5, 2016

First Posted Date

Feb 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2016

Last Update Posted Date

Feb 18, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
K-312	Experimental		Drug: K-312 100 mg Drug: K-312 100 ug C14 IV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K-312 100 mg	Drug	Single oral dose	K-312
K-312 100 ug C14 IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma-concentration time curve to last measured time point		336 hours post-dose
Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing		336 hours post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject provides written informed consent before any study-specific evaluation is performed.
Subject is a healthy adult male between the ages of 25 and 45 years, inclusive.
Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.

Exclusion Criteria:

Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312.
Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided