NCT02676830

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 2, 2016

Last Update Submit

February 16, 2016

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

K-312

EXPERIMENTAL
Drug: K-312 100 mgDrug: K-312 100 ug C14 IV

Interventions

K-312 100 mgDRUG

Single oral dose

K-312
K-312 100 ug C14 IVDRUG

microtracer dose containing ≤37 kBq (1000 nCi) \[14C\] given as a 5-ml IV push over 2 minutes

K-312

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 8, 2016

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

US(1)