Clinical trial NCT03120273: A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）
Official title: A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Effect of Drugs
Safety Issues
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First posted: 2017-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage time with the intragastric potential of hydrogen (pH)>4
timeFrame: 24 hours post-dose on Day 5
measure: Percentage time with the intragastric pH>6
timeFrame: 24 hours post-dose on Day 5
measure: The time of the intragastric pH reaching 4
timeFrame: 12 hours post-dose on Day 5
measure: The time of the intragastric pH reaching 6
timeFrame: 12 hours post-dose on Day 5
Secondary outcomes:
measure: Mean intragastric pH
timeFrame: 24 hours post-dose on Day 5
measure: Mean intragastric pH per hour
timeFrame: 24 hours post-dose on Day 5
measure: Percentage time with the intragastric pH>4 during the first 4 hours
timeFrame: 4 hours post-dose on Day 5
measure: Percentage time with the intragastric pH>6 during the first 4 hours
timeFrame: 4 hours post-dose on Day 5
measure: Percentage of the participants with duration time of intragastric pH>4 over 12h
timeFrame: 12 hours post-dose on Day 5
measure: Percentage of the participants with duration time of intragastric pH>6 over 12h
timeFrame: 12 hours post-dose on Day 5
measure: Cmax on day 1
timeFrame: 12 hours post-dose on Day 5
measure: Cmax on day 5
timeFrame: 12 hours post-dose on Day 5
measure: Area under the plasma concentration-time curve (AUC) on day 1
timeFrame: 12 hours post-dose on Day 5
measure: AUC(0-12h) on day 5
timeFrame: 12 hours post-dose on Day 5
measure: AUC(0-inf) on day 1
timeFrame: 12 hours post-dose on Day 5
measure: AUC(0-inf) on day 5
timeFrame: 12 hours post-dose on Day 5
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Lihua Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.