Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers

December 30, 2013 updated by: Kowa Research Institute, Inc.
This study will test single doses of the study drug in increasing amounts to see if it is safe.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject provides written informed consent before any study-specific evaluation is performed.
  • Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
  • Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

Exclusion Criteria:

  • Subject is a woman who is of childbearing potential or is breastfeeding.
  • Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1 Active
Drug: K-312
Experimental: Dose 2 Active
Drug: K-312
Experimental: Dose 3 Active
Drug: K-312
Experimental: Dose 4 Active
Drug: K-312
Experimental: Dose 5 Active
Drug: K-312
Experimental: Dose 6 Active
Drug: K-312
Experimental: Dose 7 Active
Drug: K-312
Placebo Comparator: Dose 1 Placebo
Drug: Placebo
Placebo Comparator: Dose 2 Placebo
Drug: Placebo
Placebo Comparator: Dose 3 Placebo
Drug: Placebo
Placebo Comparator: Dose 4 Placebo
Drug: Placebo
Placebo Comparator: Dose 5 Placebo
Drug: Placebo
Placebo Comparator: Dose 6 Placebo
Drug: Placebo
Placebo Comparator: Dose 7 Placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 10 Days
10 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 30, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • K-312-1.01US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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