Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects

NCT01489774 | Completed Phase 1 DMC

• 1 other identifier: CJ_HET_101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives

• To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects.
• To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects.
• To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 in healthy male subjects.

Conditions

Digestive System Diseases

Outcome Measures

Primary Outcomes (5)

• Area under the plasma concentration versus time curve (AUC) of CJ-12406

  Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Number of participants with adverse events

  A range of 17 days - from screening to gollow-up visit

• Peak plasma concentration (Cmax) of CJ-12406

  Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Area under the plasma concentration versus time curve (AUC) of active metabolite

  Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Peak plasma concentration (Cmax) of active metabolite

  Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

Secondary Outcomes (2)

• H. pylori eradication rate

  38 days post dose (plus of minus 1 day)

• The percent time of intragastric pH>4

  7 days post dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CJ-12406

EXPERIMENTAL

CJ-12406 Tablet, daily for 1 day or bid for 10 days

Drug: CJ-12406

Interventions

Placebo DRUG

single and multiple dose

Placebo

CJ-12406 DRUG

single and multiple dose

CJ-12406

Eligibility Criteria

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

You may qualify if:

• Male volunteers in the age between 20 and 45 years old
• Subjects with no history of any significant chronic disease
• The weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
• Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
• Available for the entire study period
• Willing to adhere to protocol requirements and sign a informed consent form
• Multiple escalation study; H. pylori positive, as determined by the urea breath test

You may not qualify if:

• History of clinically significant allergies including drug allergies
• History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
• Symptom of an acute illness within 4 weeks prior to drug administration
• History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
• Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration
• Clinical laboratory test values are outside the accepted normal range
• AST or ALT \>1.25 times to normal range
• Creatinine clearance \<80 mL/min
• lead ECG; PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec
• Clinically significant vital signs
• Hypotension (SBP ≤ 89 mmHg)
• Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg)
• Tachycardia (≥ 101 beats/min)
• History of drug and alcohol abuse(alcohol \> 30 g/day)
• Subjects who have ever smoke within 3 months prior to drug administration

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, 614-735, South Korea

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Jae-Gook Shin, MD. PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: December 12, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

KR (1)