Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers

2014-08-27 03:15:41 | BioPortfolio


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


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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic




[2-13C] uracil, [2-13C] uracil, placebo


Covance Clinical Pharmacology, Inc.
United States


Active, not recruiting


Otsuka Pharmaceutical Co., Ltd.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:41-0400

Clinical Trials [98 Associated Clinical Trials listed on BioPortfolio]

S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividi...

A Phase II Study of Tegafur-Uracil as Maintenance Chemotherapy in Patients With Stage II Microsatellite-Stable or Low-Level Microsatellite-Instability Colon Cancer

we would like to assess the efficacy and safety of tegafur-uracil in patients with stage II MSI-L or MSS colon cancer under metronomic setting for one year.

Study of 0.1% Uracil Ointment (1UO) Ointment for the Prevention of Hand-Foot Syndrome

The purpose of this research study is to see if combining uracil ointment (1UO) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects 1UO and cap...

Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines

In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by indiv...

Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Ph...

PubMed Articles [969 Associated PubMed Articles listed on BioPortfolio]

Microbial production of uracil by an isolated Methylobacterium sp. WJ4 using methanol.

In this study, we report the production of uracil from methanol by an isolated methylotrophic bacterium, Methylobacterium sp. WJ4. The use of methanol as alternative carbon feedstock is attractive opt...

Unscheduled DNA synthesis leads to elevated uracil residues at highly transcribed genomic loci in Saccharomyces cerevisiae.

Recombination and mutagenesis are elevated by active transcription. The correlation between transcription and genome instability is largely explained by the topological and structural changes in DNA a...

Binding and structural studies of the complexes of type 1 ribosome inactivating protein from Momordica balsamina with uracil and uridine.

Ribosome inactivating protein (RIP) catalyzes the cleavage of glycosidic bond formed between adenine and ribose sugar of ribosomal RNA to inactivate ribosomes. Previous structural studies have shown t...

A gene encoding a DUF523 domain protein is involved in the conversion of 2-thiouracil into uracil.

Modified nucleotides are present in many RNA species in all Domains of Life. While the biosynthetic pathways of such nucleotides are well studied, much less is known about the degradation of RNAs and ...

New Insight into Uracil Stacking in Water from Ab Initio Molecular Dynamics.

Nucleobases spontaneously aggregate in water by forming stacked dimers and multimers. It is assumed that the main contributions to the aggregation stem from hydrophobic and base-base dispersion intera...

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the HYDROLYSIS of the N-glycosidic bond between sugar phosphate backbone and URACIL residue during DNA synthesis.

Nitrogen mustard derivative of URACIL. It is a alkylating antineoplastic agent that is used in lymphatic malignancies, and causes mainly gastrointestinal and bone marrow damage.

Chronic delayed gastric emptying. Gastroparesis may be caused by motor dysfunction or paralysis of STOMACH muscles or may be associated with other systemic diseases such as DIABETES MELLITUS.

More From BioPortfolio on "Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers"

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Searches Linking to this Trial