A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules

A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period, Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant Following a High-Fat Meal

The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC; Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

Detailed Description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested in healthy participants to compare the BA of dexlansoprazole capsules manufactured by TOB relative to dexlansoprazole capsules manufactured by TPC, under fed conditions. The study consists of two parts: Part 1 participants will receive dexlansoprazole 30 mg capsules manufactured by TOB and TPC in a crossover fashion; Part 2 participants will receive dexlansoprazole 60 mg capsules manufactured by TOB and TPC in a crossover fashion.

The study will enroll approximately 120 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatment sequences as following:

• Part 1: Dexlansoprazole 30 mg (TOB) + Dexlansoprazole 30 mg (TPC)
• Part 1: Dexlansoprazole 30 mg (TPC) + Dexlansoprazole 30 mg (TOB)
• Part 2: Dexlansoprazole 60 mg (TOB) + Dexlansoprazole 60 mg (TPC)
• Part 2: Dexlansoprazole 60 mg (TPC) + Dexlansoprazole 60 mg (TOB)

All participants will be asked to take capsule of assigned dexlansoprazole on Day 1, 30 minutes following the beginning of a high-fat/high calorie breakfast of each treatment period.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 86 days. Participants will be contacted by phone call approximately 10 days after the last dose of study drug for a follow-up assessment.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Has a body mass index (BMI) from 18 to 30 kilogram per square meter (kg/m^2), at Screening.
2. Is willing and able to consume the high-fat/high-calorie breakfast administered during the study.

Exclusion Criteria:

1. Has a history of drug abuse (defined as any illicit drug use) or drug addiction in the 12 months prior to Screening or a history of alcohol abuse (defined as regular consumption exceeding 21 units per week [1 unit equal (=) 12 ounces (oz) beer, 1.5 oz hard liquor, or 5 oz wine]) within 1 year prior to the Screening Visit, or is unwilling to agree to abstain from alcohol and drugs throughout the study.
2. Has a positive test result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Check-in (Day -1 of Period 1).
3. Has received any known hepatic or renal clearance altering agents (example, erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc) for a period of 28 days prior to Day 1 of Period 1.
4. Has donated blood products (such as plasma) within 30 days or has donated whole blood or lost 450 milliliter (mL) or more of his or her blood volume, or had a transfusion of any blood product within 56 days prior to Day 1 of Period 1.
5. With the exception of acetaminophen, the subject has taken any excluded medication, supplements, or food products or beverages containing grapefruit or grapefruit juice, star fruit or star fruit juice, Seville-type (sour) oranges and marmalade, apple, orange, or pineapple juice, vegetables from the mustard green family (example, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats. Hormonal contraception and hormone replacement therapy are allowed, as long as the subject has been on a stable dose for a minimum of 90 days prior to Day 1 of Period 1.
6. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch nicotine gum, e-cigarettes) within 28 days prior to Check-in (Day -1 of Period 1), or has a positive cotinine test at Screening or Check-in (Day -1 of Period 1), or is unwilling to abstain from these products for the duration of the study.
7. Has received dexlansoprazole or lansoprazole in a previous clinical study or as a therapeutic agent within 6 months of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC); Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.	Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release capsules.; Drug: 30 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release capsules.
Experimental: Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB); Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.	Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release capsules.; Drug: 30 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release capsules.
Experimental: Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC); Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.	Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release capsules.; Drug: 60 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release capsules.
Experimental: Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB); Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.	Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release capsules.; Drug: 60 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole	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	Day 1 pre-dose and at multiple time points (up to 24 hours) post dose
AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole	Day 1 pre-dose and at multiple time points (up to 24 hours) post dose
AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole	Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): April 9, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: TAK-390MR-1002; U1111-1224-9781 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No