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

• 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: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

China, Beijing

Phase I Clinical Trial Department

Beijing, Beijing, China, 100005

Sponsors and Collaborators

Takeda

Investigators

• 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

More Information

• 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
• Results First Posted: May 10, 2019
• Last Update Posted: May 10, 2019
• Last Verified: February 2019

• 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:

Dexlansoprazole; Lansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action