Pharmacodynamics and Safety of CDFR0209

NCT02710994 | Completed Phase 1

• 1 other identifier: MED-CT1-14-085
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers

Conditions

Stomach Ulcer; Gastroesophageal Reflux

Keywords

Immediate release omeprazole; Integrated gastric acidity

Outcome Measures

Primary Outcomes (1)

• Mean percent decrease from baseline in integrated gastric acidity after 7th dose

  Data for 24 hour gastric pH were acquired at baseline (day -1) and day 7 of dosing with either Losec 40 mg or CDFR0209. Percent decrease from baseline in integrated gastric acidity after 7th dose = \[Baseline integrated acidity - Day 7 integrated acidity\]/ Baseline integrated acidity × 100.

  Day 7 upto 24 hours

Secondary Outcomes (1)

• Mean percent decrease from baseline in integrated gastric acidity after 1st dose

  Day 1 upto 24 hours

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Through study completion, an average of 35 days

Study Arms (2)

CDFR0209, Then Losec

EXPERIMENTAL

Subjects first received CDFR0209 each morning in a fasting state for 7 days. After a washout period of 14 days, they then received Losec 40 mg in a fasting state each morning for 7 days.

Drug: CDFR0209; Drug: Losec

Losec, Then CDFR0209

EXPERIMENTAL

Subjects first received Losec 40 mg each morning in a fasting state for 7 days. After a washout period of 14 days, they then received CDFR0209 in a fasting state each morning for 7 days.

Drug: CDFR0209; Drug: Losec

Interventions

CDFR0209 DRUG

Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg

CDFR0209, Then Losec; Losec, Then CDFR0209

Losec DRUG

Losec 40 mg

CDFR0209, Then Losec; Losec, Then CDFR0209

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 20 - 45 years
• With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9}
• Agreement with written informed consent

You may not qualify if:

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
• Inadequate result of laboratory test (especially, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL)
• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test and Helicobacter Ab IgM
• Positive result in urea breath test
• Taking OTC(Over the counter)medicine including oriental medicine within 7 days
• Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
• Subject with known for hypersensitivity reaction to omeprazole and sodium bicarbonate
• Previous whole blood donation within 60 days or component blood donation within 30 days
• Previous participation of other trial within 90 days
• Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• CTC Bio, Inc.: collaborator

Study Sites (1)

Ajou University Medical Center

Suwon, Gyeonggi-do, 443-380, South Korea

Location

MeSH Terms

Conditions

Stomach Ulcer; Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Doo-Yeoun Cho, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 17, 2016
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)