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

Tracking Information

• First Submitted Date: October 18, 2017
• First Posted Date: October 23, 2017
• Results First Submitted Date: February 8, 2019
• Results First Posted Date: May 10, 2019
• Last Update Posted Date: May 10, 2019
• Actual Study Start Date: November 22, 2017
• Actual Primary Completion Date: February 8, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Volunteers

Intervention

Drug: Dexlansoprazole

Dexlansoprazole delayed-release capsule.

Other Name: TAK-390 Modified Release (TAK-390MR) dexlansoprazole

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 18, 2017): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 8, 2018
• Actual Primary Completion Date: February 8, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03316976
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Takeda
• Study Sponsor: Takeda
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Takeda

• PRS Account: Takeda
• Verification Date: February 2019