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

Safety Issues Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03120273
• Other study ID #: ASKC263-LC-1-2
• 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
• 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.

Related Conditions & MeSH terms

• Effect of Drugs
• Safety Issues

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