A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）

A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole

This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection after multiple intravenous administration in healthy Chinese adults.

Study Overview

• Status: Unknown
• Conditions: Safety Issues; Effect of Drugs
• Intervention / Treatment: Drug: Dexlansoprazole Injection; Drug: Lansoprazole Injection

Detailed Description

This is a single center, open-label, multiple-dose clinical trial. 5 dosing groups were designed, including 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days, and 30 mg q12h in an active comparator, lansoprazole, treatment arm for 5 days. The study will enroll approximately 70 participants with 14 cases in each group. Participants will make 3 visits to the clinic including 8-day of confinement to the clinic.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lihua Wu, Doctor; Phone Number: 86-13819195192; Email: lihuawu73@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • First affiliated Hospital of Zhejiang University
      • Contact: Lihua Wu, Doctor; Phone Number: 86 571 87236560; Email: lihuawu73@163.com
      • Contact: Jian Liu, Master; Phone Number: 86 571 87236560; Email: lindaliu87@163.com
      • Principal Investigator: Lihua Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥18 Years;
• Male (weight ≥50kg) or female (weight ≥45kg);
• Body mass index (BMI) between 19~28 kg/m2;
• In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
• Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;
• Female participant of childbearing potential must have a negative serum pregnancy test at screening, and agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 6 months following the last dose of study drug;
• Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

Exclusion Criteria:

• Positive breath test result for H pylori at Screening;
• Cannot tolerate placement of the pH probe;
• Has poor peripheral venous access;
• Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
• Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
• Human immunodeficiency virus(HIV), hepatitis B virus(HBV), or syphilis positive;
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;
• Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
• Participation in another study with an investigational drug within the last 3 months preceding this study;
• Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
• Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexlansoprazole Injection; 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days	Drug: Dexlansoprazole Injection; 15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days
Active Comparator: Lansoprazole Injection; 30 mg q12h in lansoprazole treatment arm for 5 days.	Drug: Lansoprazole Injection; 30 mg q12h for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage time with the intragastric potential of hydrogen (pH)>4	Duration of intragastric pH>4 within 24 hours postdose	24 hours post-dose on Day 5
Percentage time with the intragastric pH>6	Duration of intragastric pH>6 within 24 hours postdose	24 hours post-dose on Day 5
The time of the intragastric pH reaching 4	The time of intragastric pH reaching 4 after the last dose	12 hours post-dose on Day 5
The time of the intragastric pH reaching 6	The time of intragastric pH reaching 6 after the last dose	12 hours post-dose on Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intragastric pH	Mean intragastric pH	24 hours post-dose on Day 5
Mean intragastric pH per hour	Mean intragastric pH per hour	24 hours post-dose on Day 5
Percentage time with the intragastric pH>4 during the first 4 hours	Duration of intragastric pH>4 within first 4 hours postdose	4 hours post-dose on Day 5
Percentage time with the intragastric pH>6 during the first 4 hours	Duration of intragastric pH>6 within first 4 hours postdose	4 hours post-dose on Day 5
Percentage of the participants with duration time of intragastric pH>4 over 12h	Numbers of participants with duration time of intragastric pH>4 over 12h	12 hours post-dose on Day 5
Percentage of the participants with duration time of intragastric pH>6 over 12h	Numbers of participants with duration time of intragastric pH>6 over 12h	12 hours post-dose on Day 5
Cmax on day 1	Maximum observed plasma concentration for dexlansoprazole	12 hours post-dose on Day 5
Cmax on day 5	Maximum observed plasma concentration for dexlansoprazole	12 hours post-dose on Day 5
Area under the plasma concentration-time curve (AUC) on day 1	AUC from time 0 to the time of the last quantifiable concentration on day 1	12 hours post-dose on Day 5
AUC(0-12h) on day 5	AUC from time 0 to the time of the last quantifiable concentration on day 5	12 hours post-dose on Day 5
AUC(0-inf) on day 1	AUC from time 0 to extrapolated to infinity on day 1	12 hours post-dose on Day 5
AUC(0-inf) on day 5	AUC from time 0 to extrapolated to infinity on day 5	12 hours post-dose on Day 5

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Lihua Wu, Doctor, Zhejiang University

Publications and helpful links

General Publications

• Wu L, Liu J, Zheng Y, Zhai Y, Lin M, Wu G, Lv D, Shentu J. Pharmacokinetic/Pharmacodynamic Evaluation of Dexlansoprazole Infusion Injection Compared with Lansoprazole in Healthy Chinese Adults. Clin Drug Investig. 2019 Oct;39(10):953-965. doi: 10.1007/s40261-019-00824-2.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 5, 2017
• Primary Completion (Anticipated): August 31, 2017
• Study Completion (Anticipated): September 30, 2017

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: ASKC263-LC-1-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No