Healthy VolunteersPhase 3NCT02037477

Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)

A Phase 3 study testing Vonoprazan, Esomeprazole and Rabeprazole sodium in people with Healthy Volunteers, run by Takeda at 1 site in Japan.

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 investigate the acid-inhibitory effect of multiple oral doses of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the CYP2C19 extensive metabolizer (EM) genotype. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Vonoprazan, Esomeprazole and Rabeprazole sodium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteJapan
Study dates: Jan 2014to Mar 2014
Phase: Phase 3
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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Is a healthy Japanese adult male volunteer.
Is aged 20 to 45 years, inclusive, at the time of informed consent.
Has been confirmed at CYP2C19 genotyping as an Extensive Metabolizer [EM (*1/*1,*1/*2,*1/*3)].
Capable of understanding and complying with the protocol requirements.
The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
Weighs 50 kg or more and has body mass index (BMI) of 18.5 or more and less than 25.0 kg/m^2 at Screening or admission (Day -3).
H. pylori-negative at Screening.

Who cannot join

Has undergone resection of the upper gastrointestinal tract or vagotomy.
Was determined to have hypoacidity or anacidity.
Has a present or past history of acid-related disease (reflux esophagitis, gastric ulcer, duodenal ulcer, non-erosive gastroesophageal reflux, Barrett's esophagus, Zollinger-Ellison syndrome, etc.).
Has undergone eradication of H. pylori within 6 months prior to the start of the study drug administration.
Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormalities which may impact the ability of the subject to participate or potentially confound the study results.
Has a known hypersensitivities or allergies to drugs or food.

Show all 20Show fewer

Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the start of the study drug administration.
Has poor peripheral venous access.
Had 200 mL or more of whole blood drawn within 4 weeks (28 days) prior to the start of the study drug administration or 400 mL or more of whole blood drawn within 12 weeks (84 days) prior to the start of the study drug administration.
Had a total volume of 800 mL or more of whole blood drawn within 52 weeks (364 days) prior to the start of the study drug administration.
Has undergone blood component draw within 2 weeks (14 days) prior to the start of the study drug administration.
Requires treatment with any of the excluded medications specified in the study or requires nutrition with any vitamin supplements or foods prohibited in the study.
Has received study medication within 16 weeks (112 days) prior to the start of the study drug administration.
Has received vonoprazan (TAK-438) in the past.
Has a history of cancer.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen or serological reaction for syphilis at Screening.
Has a Screening or admission (Day -3) abnormal clinically significant electrocardiogram (ECG).
Has abnormal Screening or admission (Day -3) laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > twice the upper limit of the normal range.
Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
Participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reasons.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka, Fukuoka

Other trials in Japan

About this study

Official title: Phase 3 Open-Label Crossover Pharmacodynamic Study to Evaluate the Acid-inhibitory Effect of TAK-438 20 mg With Esomeprazole 20 mg or Rabeprazole Sodium 10 mg in Healthy Adult Male Subjects

Read the detailed description

This is a Phase 3 open-label crossover study to evaluate the acid-inhibitory effect following 7 days multiple doses of vonoprazan (20 mg per dose) and esomeprazole (20 mg per dose) (Cohort 1) or vonoprazan (20 mg per dose) and rabeprazole sodium (10 mg per dose) (Cohort 2) in healthy Japanese adult male participants (CYP2C19 genotype: EM). There will be a total of 20 participants, 5 per group for both Cohorts 1 and 2. At least 2 participants each with the homo EM (*1/*1) or hetero EM (*1/*2, *1/*3) CYP2C19 genotype will be enrolled among the 5 participants per group.

The drug being tested in this study is called vonoprazan. This study will look at the acid inhibitory effect following 7 days multiple doses of vonoprazan and esomeprazole (Cohort 1) or vonoprazan and rabeprazole sodium (Cohort 2) in healthy Japanese adult male participants with the CYP2C19 EM genotype.

The study will enroll a total of 20 participants, 5 per group for both Cohorts. At least 2 participants each with the homo EM (*1/*1) or hetero EM (*1/*2, *1/*3) CYP2C19 genotype will be enrolled among the 5 participants per group.

Group A, Cohort 1: vonoprazan (20 mg per dose for 7 days) followed by esomeprazole (20 mg per dose for 7 days)
Group B, Cohort 1: esomeprazole (20 mg per dose for 7 days) followed by TAK-438 (20 mg per dose for 7 days)
Group C, Cohort 2: vonoprazan (20 mg per dose for 7 days) followed by rabeprazole sodium (10 mg per dose for 7 days)
Group D, Cohort 2: rabeprazole sodium (10 mg per dose for 7 days) followed by vonoprazan (20 mg per dose for 7 days).

All participants will be asked to take Study Medication at the same time each day throughout the study. This single center trial will be conducted in Japan. The overall time to participate in this study is 31 days.

Conditions: Healthy Volunteers
Being tested: Vonoprazan, Esomeprazole, Rabeprazole sodium

What participants receive

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

VonoprazanDrug
Also called TAK-438, Takecab®
Vonoprazan tablets
EsomeprazoleDrug
Also called Nexium (esomeprazole)
Esomeprazole capsules
Rabeprazole sodiumDrug
Also called Pariet (rabeprazole)
Rabeprazole sodium tablets

Study groups in NCT02037477
Study group	Role	What they receive
Sequence A (Cohort 1): Vonoprazan + Esomeprazole	Experimental	Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then esomeprazole 20 mg, orally, once daily for 7 days. Receives: Drug: Vonoprazan; Drug: Esomeprazole
Sequence B (Cohort 1): Esomeprazole + Vonoprazan	Experimental	Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then vonoprazan 20 mg, orally, once daily for 7 days. Receives: Drug: Vonoprazan; Drug: Esomeprazole
Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium	Experimental	Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then Rabeprazole sodium 10 mg, orally, once daily for 7 days. Receives: Drug: Vonoprazan; Drug: Rabeprazole sodium
Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan	Experimental	Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then vonoprazan 20 mg, orally, once daily for 7 days. Receives: Drug: Vonoprazan; Drug: Rabeprazole sodium

What is being measured

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

Intragastric pH Time Course Over 24 Hours
Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.
Measured: At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)

Secondary outcomes (4)

Frequency of Adverse Events
The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
Measured: 31 days
Number of Participants With Abnormal Changes From Baseline in Vital Signs
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
Measured: At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)
Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings
Measured: At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)
Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported.
Measured: At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)

Timeline

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

Jan 2014Mar 2014

First posted16 Jan 2014 (estimated)
Study startJan 2014
Primary completionMar 2014
Study completionMar 2014

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02037477
Sponsor's protocol ID: TAK-438/CPH-010
Other IDs: U1111-1152-3926, NCT02037477, JapicCTI-142411, JapicCTI-R150821
Status last verified: Aug 2016
First submitted: 14 Jan 2014
Last updated: 17 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Open-Label Crossover Pharmacodynamic Study to Evaluate the Acid-inhibitory Effect of TAK-438 20 mg With Esomeprazole 20 mg or Rabeprazole Sodium 10 mg in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT02037477
Acronym / sponsor ID: TAK-438/CPH-010
Conditions: Healthy Volunteers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 16 Jan 2014 (estimated)
Results: Posted 17 Oct 2016

Clinical summary

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

Detailed description

Group A, Cohort 1: vonoprazan (20 mg per dose for 7 days) followed by esomeprazole (20 mg per dose for 7 days)
Group B, Cohort 1: esomeprazole (20 mg per dose for 7 days) followed by TAK-438 (20 mg per dose for 7 days)
Group C, Cohort 2: vonoprazan (20 mg per dose for 7 days) followed by rabeprazole sodium (10 mg per dose for 7 days)
Group D, Cohort 2: rabeprazole sodium (10 mg per dose for 7 days) followed by vonoprazan (20 mg per dose for 7 days).

Study design

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

Arm	Type	Receives
Sequence A (Cohort 1): Vonoprazan + Esomeprazole	Experimental	Drug: Vonoprazan, Drug: EsomeprazoleVonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then esomeprazole 20 mg, orally, once daily for 7 days.
Sequence B (Cohort 1): Esomeprazole + Vonoprazan	Experimental	Drug: Vonoprazan, Drug: EsomeprazoleEsomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then vonoprazan 20 mg, orally, once daily for 7 days.
Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium	Experimental	Drug: Vonoprazan, Drug: Rabeprazole sodiumVonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then Rabeprazole sodium 10 mg, orally, once daily for 7 days.
Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan	Experimental	Drug: Vonoprazan, Drug: Rabeprazole sodiumRabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then vonoprazan 20 mg, orally, once daily for 7 days.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Is a healthy Japanese adult male volunteer.
Is aged 20 to 45 years, inclusive, at the time of informed consent.
Has been confirmed at CYP2C19 genotyping as an Extensive Metabolizer [EM (*1/*1,*1/*2,*1/*3)].
Capable of understanding and complying with the protocol requirements.
The participant signs and dates a written informed consent form prior to the initiation of any study procedures.

Key exclusion criteria (20 listed)

Has undergone resection of the upper gastrointestinal tract or vagotomy.
Was determined to have hypoacidity or anacidity.
Has a present or past history of acid-related disease (reflux esophagitis, gastric ulcer, duodenal ulcer, non-erosive gastroesophageal reflux, Barrett's esophagus, Zollinger-Ellison syndrome, etc.).
Has undergone eradication of H. pylori within 6 months prior to the start of the study drug administration.
Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormalities which may impact the ability of the subject to participate or potentially confound the study results.

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
VonoprazanAlso: TAK-438, Takecab®Vonoprazan tablets	Drug	Sequence A (Cohort 1): Vonoprazan + Esomeprazole, Sequence B (Cohort 1): Esomeprazole + Vonoprazan, Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium, Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan
EsomeprazoleAlso: Nexium (esomeprazole)Esomeprazole capsules	Drug	Sequence A (Cohort 1): Vonoprazan + Esomeprazole, Sequence B (Cohort 1): Esomeprazole + Vonoprazan
Rabeprazole sodiumAlso: Pariet (rabeprazole)Rabeprazole sodium tablets	Drug	Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium, Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan

Primary outcome

Intragastric pH Time Course Over 24 Hours
Time frame: At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)
Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.

4 secondary outcomes

Frequency of Adverse Events
Time frame: 31 days
Number of Participants With Abnormal Changes From Baseline in Vital Signs
Time frame: At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)
Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings
Time frame: At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)
Number of Participants With Markedly Abnormal Laboratory Values
Time frame: At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)

Results and safety

Results posted to the registry on 17 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A (Cohort 1): Vonoprazan + Esomeprazole	5	5
Sequence B (Cohort 1): Esomeprazole + Vonoprazan	5	5
Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium	5	4
Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan	5	5

Primary outcome: Intragastric pH Time Course Over 24 Hours

Time frame: At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8). Mean (Standard Deviation). Unit: percentage of time

Measure	Cohort 1 - Vonoprazan 20 mg n = 10	Cohort 1 - Esomeprazole 20 mg n = 10	Cohort 2 - Vonoprazan 20 mg n = 7	Cohort 2 - Rabeprazole Sodium 10 mg n = 7
0-24 hr pH 4 HTR (%)-Baseline	10.63 (7.391)	10.63 (7.391)	8.90 (6.472)	8.90 (6.472)
0-24 hr pH 4 HTR (%)-Day 1	71.37 (17.030)	23.92 (16.896)	84.16 (12.383)	26.29 (13.381)
0-24 hr pH 4 HTR (%)-Day 7	85.82 (14.748)	61.21 (17.140)	93.79 (7.310)	65.09 (14.159)
0-12 hr pH 4 HTR (%)-Baseline	12.98 (11.139)	12.98 (11.139)	8.01 (5.730)	8.01 (5.730)
0-12 hr pH 4 HTR (%)-Day 1	74.83 (9.681)	34.89 (24.645)	84.03 (7.810)	37.26 (20.384)
0-12 hr pH 4 HTR (%)-Day 7	96.45 (4.402)	77.62 (17.302)	98.83 (2.968)	76.06 (9.591)
12-24 hr pH 4 HTR (%)-Baseline	8.18 (13.735)	8.18 (13.735)	9.77 (14.096)	9.77 (14.096)
12-24 hr pH 4 HTR (%)-Day 1	67.86 (28.345)	12.94 (10.876)	84.34 (20.254)	15.34 (13.317)

Population analysed: Pharmacodynamic (PD) Analysis Set - Participants receiving study medication who completed protocol procedures without serious violation of the protocol were eligible for PD analysis. All 10 subjects from Cohort 1 were included. Three subjects in Cohort 2 were excluded from the PD analysis set, which therefore consisted of 7 subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 31 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - Vonoprazan 20 mg	0 of 10 (0%)	0 of 10 (0%)	Not reported
Cohort 1 - Esomeprazole 20 mg	0 of 10 (0%)	0 of 10 (0%)	Not reported
Cohort 2 - Vonoprazan 20 mg	0 of 10 (0%)	3 of 10 (30%)	Not reported
Cohort 2 - Rabeprazole Sodium 10 mg	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

General Manager study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vonoprazan, Esomeprazole and Rabeprazole sodium in people with Healthy Volunteers, run by Takeda at 1 site in Japan.

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 7 inclusion and 20 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 17 Oct 2016. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Oct 2016). 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?

Intragastric pH Time Course Over 24 Hours (time frame: At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)). 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 NCT02037477.

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 17 Oct 2016.