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OpenTrials
Completed

NCT Number: NCT01952548

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

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

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Key information

Conditions

Safety and Tolerability

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

K-312

Drug

Placebo

Drug

Primary outcomes

  1. Adverse Events

    Time frame: 10 Days

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
Sep 30, 2013
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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