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A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316976
Recruitment Status : Completed
First Posted : October 23, 2017
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE October 23, 2017
Results First Submitted Date  ICMJE February 8, 2019
Results First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE November 22, 2017
Actual Primary Completion Date February 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
  • AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  • AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
Official Title  ICMJE A Phase 1, Single-Center, Open-Label, 2-Arm Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 mg and 60 mg Delayed-Release Capsules in Healthy Chinese Subjects
Brief Summary The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
Detailed Description

The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-release capsules in healthy participants.

The study will enroll approximately 40 participants, 20 participants in each parallel arm. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  • Group 1: A single oral dose of Dexlansoprazole 30 mg delayed-release capsule
  • Group 2: A single oral dose of Dexlansoprazole 60 mg delayed-release capsule

All participants will be asked to take single dose of study drug on Day 1.

This single center trial will be conducted in China. The overall time to participate in this study is approximately 40 days. Participants will be contacted by telephone or will make a final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a follow-up assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Dexlansoprazole
Dexlansoprazole delayed-release capsule.
Other Name: TAK-390 Modified Release (TAK-390MR) dexlansoprazole
Study Arms  ICMJE
  • Experimental: Group 1: Dexlansoprazole 30 mg
    Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
    Intervention: Drug: Dexlansoprazole
  • Experimental: Group 2: Dexlansoprazole 60 mg
    Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
    Intervention: Drug: Dexlansoprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 8, 2018
Actual Primary Completion Date February 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Is a healthy adult man or woman of Chinese descent.
  2. Is aged 18 to 45 years, inclusive, at the time of informed consent and study medication dose.
  3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m^2), inclusive at Screening Visit.

Exclusion Criteria:

  1. Has a known hypersensitivity to any component of the formulation of dexlansoprazole or other drug with the same mechanism of action (including lansoprazole, omeprazole, esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.
  2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and for 48 hours prior to each clinic visit and drugs throughout the study.
  3. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1) or is unwilling to abstain from these products for the duration of the study.
  4. Has poor peripheral venous access.
  5. Has donated blood products (such as plasma), whole blood or had a significant blood loss (450 millimeter [mL]) within 56 days of Day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03316976
Other Study ID Numbers  ICMJE TAK-390MR_106
U1111-1192-7711 ( Registry Identifier: WHO )
CTR20160792 ( Registry Identifier: SFDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP