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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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Dexlansoprazole Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 22, 2017
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Drug: Dexlansoprazole
Dexlansoprazole delayed-release capsule.
Other Name: TAK-390 Modified Release (TAK-390MR) dexlansoprazole

Experimental: Group 2: Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Drug: Dexlansoprazole
Dexlansoprazole delayed-release capsule.
Other Name: TAK-390 Modified Release (TAK-390MR) dexlansoprazole




Primary Outcome Measures :
  1. Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole [ Time Frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316976


Locations
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China, Beijing
Phase I Clinical Trial Department
Beijing, Beijing, China, 100005
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Statistical Analysis Plan  [PDF] March 22, 2018
Study Protocol  [PDF] November 28, 2017

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03316976    
Other Study ID Numbers: TAK-390MR_106
U1111-1192-7711 ( Registry Identifier: WHO )
CTR20160792 ( Registry Identifier: SFDA )
First Posted: October 23, 2017    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action