Healthy VolunteersPhase 1NCT03801148

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

A Phase 1 study testing 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC and 60 mg dexlansoprazole capsules manufactured at TOB in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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.). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC and 60 mg dexlansoprazole capsules manufactured at TOB
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2019to 9 Apr 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.
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).
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.
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.
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.
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.
Has received dexlansoprazole or lansoprazole in a previous clinical study or as a therapeutic agent within 6 months of screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Healthy Volunteers
Being tested: 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB, 60 mg dexlansoprazole capsules manufactured at TPC
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

30 mg dexlansoprazole capsules manufactured at TOBDrug
Dexlansoprazole delayed-release capsules.
30 mg dexlansoprazole capsules manufactured at TPCDrug
Dexlansoprazole delayed-release capsules.
60 mg dexlansoprazole capsules manufactured at TOBDrug
Dexlansoprazole delayed-release capsules.
60 mg dexlansoprazole capsules manufactured at TPCDrug
Dexlansoprazole delayed-release capsules.

Study groups in NCT03801148
Study group	Role	What they receive
Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)	Experimental	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. Receives: Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC
Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)	Experimental	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. Receives: Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC
Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)	Experimental	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. Receives: Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC
Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)	Experimental	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. Receives: Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 20199 Apr 2019

First posted11 Jan 2019
Study start10 Jan 2019
Primary completion25 Feb 2019
Study completion9 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03801148
Sponsor's protocol ID: TAK-390MR-1002
Other IDs: U1111-1224-9781
Status last verified: Mar 2020
First submitted: 9 Jan 2019
Last updated: 19 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03801148
Acronym / sponsor ID: TAK-390MR-1002
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 10 Jan 2019 (actual)
Primary completion: 25 Feb 2019 (actual)
Study completion: 9 Apr 2019 (actual)
First posted: 11 Jan 2019 (actual)
Results: Posted 19 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)	Experimental	Drug: 30 mg dexlansoprazole capsules manufactured at TOB, Drug: 30 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 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.
Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)	Experimental	Drug: 30 mg dexlansoprazole capsules manufactured at TOB, Drug: 30 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 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.
Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)	Experimental	Drug: 60 mg dexlansoprazole capsules manufactured at TOB, Drug: 60 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 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.
Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)	Experimental	Drug: 60 mg dexlansoprazole capsules manufactured at TOB, Drug: 60 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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.
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).
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.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
30 mg dexlansoprazole capsules manufactured at TOBDexlansoprazole delayed-release capsules.	Drug	Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC), Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)
30 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole delayed-release capsules.	Drug	Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC), Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)
60 mg dexlansoprazole capsules manufactured at TOBDexlansoprazole delayed-release capsules.	Drug	Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC), Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)
60 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole delayed-release capsules.	Drug	Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC), Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)

Primary outcome

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
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
Time frame: 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
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Results and safety

Results posted to the registry on 19 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC	31	30
Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB	31	30
Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC	30	30
Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB	30	30

Primary outcome: Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram/milliliter (ng/mL)

Measure	Part 1: Dexlansoprazole 30 mg TOB n = 60	Part 1: Dexlansoprazole 30 mg TPC n = 60	Part 2: Dexlansoprazole 60 mg TOB n = 57	Part 2: Dexlansoprazole 60 mg TPC n = 57
Value	610.1 (52.0)	622.5 (49.9)	1381 (45.3)	1302 (50.3)

Part 1: Dexlansoprazole 30 mg TOB vs Part 1: Dexlansoprazole 30 mg TPC: Geometric LSM ratio: 0.9800 (90% CI 0.9171 to 1.0473)
Part 2: Dexlansoprazole 60 mg TOB vs Part 2: Dexlansoprazole 60 mg TPC: Geometric LSM ratio: 1.0737 (90% CI 1.0025 to 1.1501)

Population analysed: The pharmacokinetic (PK) evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter(ng*hour/mL)

Measure	Part 1: Dexlansoprazole 30 mg TOB n = 60	Part 1: Dexlansoprazole 30 mg TPC n = 60	Part 2: Dexlansoprazole 60 mg TOB n = 57	Part 2: Dexlansoprazole 60 mg TPC n = 57
Value	2881 (66.8)	2756 (62.8)	6608 (58.5)	6278 (59.4)

Part 1: Dexlansoprazole 30 mg TOB vs Part 1: Dexlansoprazole 30 mg TPC: Geometric LSM ratio: 1.0455 (90% CI 1.0070 to 1.0855)
Part 2: Dexlansoprazole 60 mg TOB vs Part 2: Dexlansoprazole 60 mg TPC: Geometric LSM ratio: 1.0610 (90% CI 1.0192 to 1.1046)

Population analysed: The PK evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.

Primary outcome: 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

Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hour/mL

Measure	Part 1: Dexlansoprazole 30 mg TOB n = 58	Part 1: Dexlansoprazole 30 mg TPC n = 54	Part 2: Dexlansoprazole 60 mg TOB n = 57	Part 2: Dexlansoprazole 60 mg TPC n = 53
Value	2927 (66.2)	2885 (63.9)	6734 (60.3)	6220 (56.8)

Part 1: Dexlansoprazole 30 mg TOB vs Part 1: Dexlansoprazole 30 mg TPC: Geometric LSM ratio: 1.0553 (90% CI 1.0186 to 1.0933)
Part 2: Dexlansoprazole 60 mg TOB vs Part 2: Dexlansoprazole 60 mg TPC: GMR: 1.0468 (90% CI 1.0027 to 1.0929)

Population analysed: PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.

Primary outcome: 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

Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hour/mL

Measure	Part 1: Dexlansoprazole 30 mg TOB n = 58	Part 1: Dexlansoprazole 30 mg TPC n = 54	Part 2: Dexlansoprazole 60 mg TOB n = 57	Part 2: Dexlansoprazole 60 mg TPC n = 53
Value	2926 (66.2)	2884 (63.9)	6733 (60.3)	6217 (56.8)

Part 1: Dexlansoprazole 30 mg TOB vs Part 1: Dexlansoprazole 30 mg TPC: Geometric LSM ratio: 1.0555 (90% CI 1.0188 to 1.0935)
Part 2: Dexlansoprazole 60 mg TOB vs Part 2: Dexlansoprazole 60 mg TPC: Geometric LSM ratio: 1.0472 (90% CI 1.0029 to 1.0934)

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 37). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Dexlansoprazole 30 mg TOB	0 of 61 (0%)	4 of 61 (6.6%)	0 of 61
Part 1: Dexlansoprazole 30 mg TPC	0 of 61 (0%)	3 of 61 (4.9%)	0 of 61
Part 2: Dexlansoprazole 60 mg TOB	0 of 59 (0%)	7 of 59 (11.9%)	0 of 59
Part 2: Dexlansoprazole 60 mg TPC	0 of 59 (0%)	5 of 59 (8.5%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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

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Healthy Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole (time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03801148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.