Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Gastroparesis

In brief

The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers

Key facts

Study ID

NCT01074710

Run by

Otsuka Pharmaceutical Co., Ltd.

People needed

8

Starts

2010-02-01

Expected to finish

2010-05-01

Last updated by the study team

2010-07-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index [range is 18.5 to 29.9 kg/m2]
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs

You may not qualify if…

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed)
• History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant

Where it is running

• Covance Clinical Pharmacology, Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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