Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers

NCT ID: NCT01074710

Last Updated: 2010-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-05-31

Brief Summary

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

Detailed Description

The C13-URA Breath Test Kit is intended to be used as a diagnostic tool to identify rapid and/or delayed gastric emptying in patients who have upper GI symptoms such as stomach pain, fullness, early satiety, vomiting, etc., and who have suspected gastric emptying abnormalities such as gastroparesis or dumping syndrome.

This study will be a double-blind, placebo-controlled, 3-period safety and PK study of 13C-uracil administered as a single oral dose of 50 mg at step 1 (Period 1), 100 mg at step 2 (Period 2), and 200 mg at step 3 (Period 3) in the form of a semi-solid meal to subjects following at least a 10-hour fast from food and 2-hour fast from water. Dosing will be followed by a 6-hour fast from food and a 4-hour fast from water. There will be a washout of at least 7 days between doses.

The objectives of this study are as follows;

1)to evaluate the safety of 13C-uracil in a semi-solid meal in healthy volunteers, 2)to establish the pharmacokinetic profile of 13C-uracil in a semi-solid meal in healthy volunteers, 3)to assess the correlation between plasma concentration of 13C-uracil and urinary excretion of 13C-uracil, 4)to evaluate the reproducibility (intra/inter-individual variance) of the breath test, 5)to determine the dose for 13C-uracil that facilitates adequate Δ13C in breath expired by healthy volunteers

Conditions

Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

C13-URA

administered C13-URA 50, 100, 200mg in same subjects

Group Type: EXPERIMENTAL

[2-13C] uracil

Intervention Type: DRUG

po, in the form of semi-solid meal, granules, once a period

Placebo

2 same subjects

Group Type: PLACEBO_COMPARATOR

[2-13C] uracil, placebo

Intervention Type: DRUG

po, in the form of semi-solid meal, granules, once a period

Interventions

[2-13C] uracil

po, in the form of semi-solid meal, granules, once a period

Intervention Type: DRUG

[2-13C] uracil, placebo

po, in the form of semi-solid meal, granules, once a period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

R&D Department, Diagnostic Division

Principal Investigators

Stephen D Flach, MD, PhD, CPI

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Pharmacology, Inc.

Locations

Covance Clinical Pharmacology, Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

URA-09-001

Identifier Type: -

Identifier Source: org_study_id