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
• 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. primary completion date: December 2013
• 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

• Safety and Tolerability

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