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

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01952548
• Collaborator: (none)
• Location: 1
• Arms: 14

Study Details

Study Description

Brief Summary

This study will test single doses of the study drug in increasing amounts to see if it is safe.

Condition or Disease	Intervention/Treatment	Phase
Safety and Tolerability	Drug: K-312; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse Events [10 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Austin	Texas	United States

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01952548
• Other Study ID Numbers: K-312-1.01US
• First Posted: Sep 30, 2013
• Last Update Posted: Dec 31, 2013
• Last Verified: Dec 1, 2013

Study Results

No Results Posted as of Dec 31, 2013