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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03120273
Other study ID # ASKC263-LC-1-2
Secondary ID
Status Recruiting
Phase Phase 1
First received March 28, 2017
Last updated April 14, 2017
Start date May 5, 2017
Est. completion date September 30, 2017

Study information

Verified date March 2017
Source First Affiliated Hospital of Zhejiang University
Contact Lihua Wu, Doctor
Phone 86-13819195192
Email lihuawu73@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date September 30, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexlansoprazole Injection
15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days
Lansoprazole Injection
30 mg q12h for 5 days.

Locations

Country Name City State
China First affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Percentage time with the intragastric pH>6 Duration of intragastric pH>6 within 24 hours postdose 24 hours post-dose on Day 5
Primary 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
Primary 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 Mean intragastric pH Mean intragastric pH 24 hours post-dose on Day 5
Secondary Mean intragastric pH per hour Mean intragastric pH per hour 24 hours post-dose on Day 5
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Cmax on day 1 Maximum observed plasma concentration for dexlansoprazole 12 hours post-dose on Day 5
Secondary Cmax on day 5 Maximum observed plasma concentration for dexlansoprazole 12 hours post-dose on Day 5
Secondary 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
Secondary 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
Secondary AUC(0-inf) on day 1 AUC from time 0 to extrapolated to infinity on day 1 12 hours post-dose on Day 5
Secondary AUC(0-inf) on day 5 AUC from time 0 to extrapolated to infinity on day 5 12 hours post-dose on Day 5
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