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NCT01952548 Clinical Trial

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

Safety and Tolerability Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01952548
Other study ID # K-312-1.01US
Secondary ID
Status Completed
Phase Phase 1
First received September 19, 2013
Last updated December 30, 2013
Start date May 2013

Study information
Verified date December 2013
Source Kowa Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• K-312

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events 10 Days
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