NCT03120273

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

April 19, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

March 28, 2017

Last Update Submit

April 14, 2017

Conditions

Effect of DrugsSafety Issues

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Mean intragastric pH

    24 hours post-dose on Day 5

  • Mean intragastric pH per hour

    24 hours post-dose on Day 5

  • Percentage time with the intragastric pH>4 during the first 4 hours

    4 hours post-dose on Day 5

  • Percentage time with the intragastric pH>6 during the first 4 hours

    4 hours post-dose on Day 5

  • Percentage of the participants with duration time of intragastric pH>4 over 12h

    12 hours post-dose on Day 5

  • +7 more secondary outcomes

Study Arms (2)

Dexlansoprazole Injection

EXPERIMENTAL

15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days

Drug: Dexlansoprazole Injection

Lansoprazole Injection

ACTIVE COMPARATOR

30 mg q12h in lansoprazole treatment arm for 5 days.

Drug: Lansoprazole Injection

Interventions

Dexlansoprazole InjectionDRUG

15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days

Dexlansoprazole Injection
Lansoprazole InjectionDRUG

30 mg q12h for 5 days.

Lansoprazole Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31338800DERIVED

MeSH Terms

Interventions

DexlansoprazoleLansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lihua Wu, Doctor

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihua Wu, Doctor

CONTACT

86-13819195192lihuawu73@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 19, 2017

Study Start

May 5, 2017

Primary Completion

August 31, 2017

Study Completion

September 30, 2017

Last Updated

April 19, 2017

Record last verified: 2017-03

Locations

CN(1)