Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)

NCT03457311 | Unknown Phase 3 DMC

• 1 other identifier: Oral GSP-001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to determine the oral galactose single point (OGSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between OGSP and other hepatic function assessment methods among this trial subjects.

Conditions

Galactose Single Point (GSP), Residual Liver Function

Keywords

GSP, oral galactose single point (OGSP)

Outcome Measures

Primary Outcomes (1)

• Blood concentration of oral galactose

  To determine the OGSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function

  Sixty minutes

Study Arms (1)

OGSP measurement

OTHER

For the OGSP measurement, subjects will be orally administered with 1.25 ml/kg G.S.P. oral solution (400 mg/ml of galactose). At least 20 ml water will be given to subjects after drinking G.S.P. oral solution within 3 to 5 minutes. Sixty minutes after oral G.S.P. solution, a sample of 0.5 ml of whole blood will be taken from subject's finger for the determination of OGSP value.

Drug: G.S.P. Oral Solution 400 mg/ml

Interventions

G.S.P. Oral Solution 400 mg/ml DRUG

Oral 1.25 ml/kg BW G.S.P. oral solution after fasting for 6 hours.

OGSP measurement

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must fulfill all of the following criteria to be eligible for the study:
• Male or female with age between 20-85.
• Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

You may not qualify if:

• Any of the following criteria will disqualify the subject from participation:
• History of serious allergic reaction to galactose and have galactosemia.
• History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
• History of diabetes mellitus.
• Subjects are children or handicapped people.
• Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

Sponsors & Collaborators

• Richever Enterprise Co., Ltd.: lead

MeSH Terms

Conditions

Pseudohypoparathyroidism

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: September 9, 2013
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-02