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

Phase 1

Completed

• Conditions: Safety and Tolerability
• Interventions: Drug: K-312; Drug: Placebo

• Registration Number: NCT01952548
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Last Update Submitted: 2013-12-30
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 3 Active	K-312	-
Dose 4 Active	K-312	-
Dose 5 Active	K-312	-
Dose 7 Active	K-312	-
Dose 1 Placebo	Placebo	-
Dose 2 Placebo	Placebo	-
Dose 1 Active	K-312	-
Dose 2 Active	K-312	-
Dose 3 Placebo	Placebo	-
Dose 4 Placebo	Placebo	-
Dose 5 Placebo	Placebo	-
Dose 6 Placebo	Placebo	-
Dose 7 Placebo	Placebo	-
Dose 6 Active	K-312	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	10 Days