Erosive Esophagitis(EE)Phase 1TAK-438_107NCT02141711

TAK-438 - Safety, Blood Levels & Effects of Repeated Doses

A Phase 1 study testing TAK-438 in people with Erosive Esophagitis(EE) and Gastroesophageal Reflux Disease (GERD), run by Takeda at 1 site in United Kingdom.

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 evaluate the safety, tolerability, and pharmacokinetics of TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind, placebo controlled, sequential panel, multiple-dose schedule. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Erosive Esophagitis(EE), Gastroesophageal Reflux Disease (GERD)
What is being tested?: TAK-438
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2008to Feb 2009
Phase: Phase 1
Are there results?: None posted in the registry

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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male subjects aged 18 to 45, inclusive, who are in good health, as determined by medical history, physical examination, clinical laboratory evaluations and urine drug screen.
The subject has the ability to tolerate the pH probe for 24 hours prior to Randomization (Day 1).

Who cannot join

Clinically significant history of hypersensitivity to any drug or food or any excipients of TAK-438
History of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer,gastric ulcer, dyspepsia, Barrett's esophagus, or Zollinger-Ellison syndrome
The subject has a positive test result for Helicobacter pylori at the Initial Screening Visit
Any clinically significant results from physical examinations or clinical laboratory results as deemed by the investigator.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Medicines Research
London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Multiple Repeat Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Non-Japanese Male Subjects

Read the detailed description

The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a safe and well-tolerated dose. This study looked at pharmacokinetic (effect of the body on the drug) and pharmacodynamic properties (effect of the drug on the body) as well as look at lab results and side effects in people who took TAK-438. This study was designed as a randomized, sequential-panel, multiple repeat dose study.

The study population consisted of 4 Cohorts with 12 participants in each Cohort; with 9 participants randomized to receive a single dose of TAK-438, and 3 participants to receive placebo. Participants in each Cohort received a single dose of study drug once daily after a 10-hour fast. The starting dose was 10 mg followed by administrations of 20, 40, and 30 mg.

This single-centre trial was conducted in the United Kingdom. The overall time to participate in this study was up to 37 days. Participants made 2 visits to the clinic for screening, one 11-day period of confinement to the clinic, and 2 further visits after the confinement period. All participants were contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Conditions: Erosive Esophagitis(EE), Gastroesophageal Reflux Disease (GERD)
Being tested: TAK-438, TAK-438 Placebo
Keywords: Drug therapy
Medical subject headings: Gastroesophageal Reflux

What participants receive

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

TAK-438Drug
TAK-438 tablets
TAK-438 PlaceboDrug
TAK-438 placebo-matching tablets

Study groups in NCT02141711
Study group	Role	What they receive
Cohort 1: TAK-438 10 mg	Experimental	TAK-438 10 mg tablets, orally, once, daily, for 7 days. Receives: Drug: TAK-438
Cohort 2: TAK-438 20 mg	Experimental	TAK-438 20 mg tablets, orally, once, daily, for 7 days. Receives: Drug: TAK-438
Cohort 3: TAK-438 40 mg	Experimental	TAK-438 40 mg tablets, orally, once, daily, for 7 days. Receives: Drug: TAK-438
Cohort 4: TAK-438 30 mg	Experimental	TAK-438 30 mg tablets, orally, once, daily, for 7 days. Receives: Drug: TAK-438
Cohorts 1-4: Placebo	Placebo comparator	TAK-438 placebo-matching tablets, orally, once, daily, for 7 days. Receives: Drug: TAK-438 Placebo

What is being measured

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

AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).
Measured: Days 1 and 7
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Days 1 and 7
AUC(0-tau): Area Under the Plasma Concentration-time Curve from Time 0 to Time tau Over the Dosing Interval for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval.
Measured: Days 1 and 7
Cmax: Maximum Observed Plasma Concentration for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Days 1 and 7
Cmin,ss: Minimum Observed Plasma Concentration at Steady State for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Measured: Day 7
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Measured: Day 7
(Cmax-Cmin)/Cavg: Fluctuation of Concentration at Steady State for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
(Cmax-Cmin)/Cavg, where Cmin is the minimum observed plasma concentration and Cavg is the average plasma concentration at steady state.
Measured: Day 7
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: Days 1 and 7
Terminal Elimination Rate Constant (λz) for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Measured: Days 1 and 7
Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Days 1 and 7
Apparent Clearance (CL/F) Pharmacokinetic Parameter for TAK-438
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
Measured: Days 1 and 7
Apparent Volume of Distribution (Vz/F) for TAK-438
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.
Measured: Days 1 and 7
Ae(0-t): Total Amount of Drug Excreted in Urine from Time 0 to Time T for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Ae(0-t) is the total amount of drug excreted in urine from time 0 to t, where t is 24 hours on Day 1 and 48 hours on Day 7.
Measured: Day 1 and Day 7
Ae(0-tau): Total Amount of Drug Excreted in Urine from Time 0 to Time tau for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Ae(0-tau) is the total amount of drug excreted in urine from time 0 to tau, where tau equals 24 hours.
Measured: Day 1 and Day 7
Renal Clearance (CLr) for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.
Measured: Day 1 and Day 7
Fraction of TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul Excreted in Urine (Fe)
Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100.
Measured: Day 1 and Day 7
Physical Examination Findings
A baseline physical examination (defined as the pretreatment assessment immediately prior to the start of study drug) will consist of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; (11) genitourinary system; and (12) other. All subsequent physical examinations should assess clinically significant changes from the baseline examination.
Measured: Baseline up to Day 9
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Participants with at least one potentially clinically significant post-baseline vital sign finding. Vital signs will include body temperature (oral temperature), sitting blood pressure (after sitting for 5 minutes), and pulse (bpm).
Measured: Baseline up to Day 9
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Full 12-lead ECGs will be recorded using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (using Bazett correction; QTcB) intervals. The investigator or other qualified physician will interpret each ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Measured: Baseline to Day 9
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Laboratory tests for hematology, serum chemistries, coagulation tests, and urinalysis will be performed.
Measured: Baseline up to Day 9
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Treatment-emergent 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 through 7 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Measured: Baseline up to Day 9
Safety of TAK-438
Assessed by physical examination, ECG, and safety tests of blood/urine
Measured: 3 months
Tolerability of TAK-438
Assessed by adverse events
Measured: 3 months
Pharmacokinetic analysis of plasma TAK-438 concentrations
Primary pharmacokinetic parameters (AUC (0-tlqc), AUC (0-inf), Cmax) for TAK-438 and its metabolites M-I, M-II, M-III and M-IV-Sul will be subject to statistical analysis
Measured: 3 months
Pharmacodynamic measurement for assay of gastric pH, measurement of gastrin, pepsinogen I, pepsinogen II and the pepsinogen I/II ratio in plasma samples
Measured: 3 months

Secondary outcomes (7)

Percentage of Time the pH is Greater than pH 4 and pH 5 over a 24 Hour Period
Using a calibrated gastric pH monitor, the measurement of stomach pH will be made continuously over a 24-hour period at Baseline and over a 24-hour period following the administration of study on Days 1, 4 and 7.
Measured: Over a 24-hour period at Baseline and over a 24-hour period following the administration of study on Days 1, 4 and 7
Percentage of Time the pH is Greater than pH 4 and pH 5 over a 48 Hour Period
Using a calibrated gastric pH monitor, the measurement of stomach pH will be made continuously over a 48-hour period following the administration of study drug on Day 7.
Measured: Over a 48-hour period following the administration of study on Day 7
Percentage of Time the PH is Greater than pH 4 and pH 5 from 8 PM to 8 AM
Using a calibrated gastric pH monitor, the measurement of stomach pH will be made continuously over a 12-hour period from 8 PM to 8 AM to assess nocturnal pH.
Measured: Over a 12-hour period from 8 PM to 8 AM on Days 1, 4 and 7
Total Amount of Gastrin in Plasma
Measured: Predose Days 1 through 7 and Days 8 and 9
Total Amount of Pepsinogen I in Plasma
Measured: Predose Days 1 through 7 and Days 8 and 9
Total Amount of Pepsinogen II in Plasma
Measured: Predose Days 1 through 7 and Days 8 and 9
Pepsinogen I/II Ratio in Plasma
Measured: Predose Days 1 through 7 and Days 8 and 9

Timeline

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

Oct 2008Feb 2009

First posted19 May 2014 (estimated)
Study startOct 2008
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Erosive Esophagitis(EE)Studies 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: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02141711
Sponsor's protocol ID: TAK-438_107
Other IDs: U1111-1153-8443, 2008-004975-22, 2008
Acronym: TAK-438_107
Status last verified: May 2014
First submitted: 15 May 2014
Last updated: 19 May 2014
Results posted: No
Data monitoring committee: No

Publications

Jenkins H, Sakurai Y, Nishimura A, Okamoto H, Hibberd M, Jenkins R, Yoneyama T, Ashida K, Ogama Y, Warrington S. Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015 Apr;41(7):636-48. doi: 10.1111/apt.13121. Epub 2015 Feb 23.
PubMed 25707624

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Multiple Repeat Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Non-Japanese Male Subjects
ClinicalTrials.gov ID: NCT02141711
Acronym / sponsor ID: TAK-438_107 / TAK-438_107
Conditions: Erosive Esophagitis(EE), Gastroesophageal Reflux Disease (GERD)
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 19 May 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Cohort 1: TAK-438 10 mg	Experimental	Drug: TAK-438TAK-438 10 mg tablets, orally, once, daily, for 7 days.
Cohort 2: TAK-438 20 mg	Experimental	Drug: TAK-438TAK-438 20 mg tablets, orally, once, daily, for 7 days.
Cohort 3: TAK-438 40 mg	Experimental	Drug: TAK-438TAK-438 40 mg tablets, orally, once, daily, for 7 days.
Cohort 4: TAK-438 30 mg	Experimental	Drug: TAK-438TAK-438 30 mg tablets, orally, once, daily, for 7 days.
Cohorts 1-4: Placebo	Placebo comparator	Drug: TAK-438 PlaceboTAK-438 placebo-matching tablets, orally, once, daily, for 7 days.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male subjects aged 18 to 45, inclusive, who are in good health, as determined by medical history, physical examination, clinical laboratory evaluations and urine drug screen.
The subject has the ability to tolerate the pH probe for 24 hours prior to Randomization (Day 1).

Key exclusion criteria (4 listed)

Clinically significant history of hypersensitivity to any drug or food or any excipients of TAK-438
History of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer,gastric ulcer, dyspepsia, Barrett's esophagus, or Zollinger-Ellison syndrome
The subject has a positive test result for Helicobacter pylori at the Initial Screening Visit
Any clinically significant results from physical examinations or clinical laboratory results as deemed by the investigator.

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
TAK-438TAK-438 tablets	Drug	Cohort 1: TAK-438 10 mg, Cohort 2: TAK-438 20 mg, Cohort 3: TAK-438 40 mg, Cohort 4: TAK-438 30 mg
TAK-438 PlaceboTAK-438 placebo-matching tablets	Drug	Cohorts 1-4: Placebo

Primary outcome

AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
AUC(0-tau): Area Under the Plasma Concentration-time Curve from Time 0 to Time tau Over the Dosing Interval for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval.
Cmax: Maximum Observed Plasma Concentration for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Cmin,ss: Minimum Observed Plasma Concentration at Steady State for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Day 7
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Day 7
(Cmax-Cmin)/Cavg: Fluctuation of Concentration at Steady State for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Day 7
(Cmax-Cmin)/Cavg, where Cmin is the minimum observed plasma concentration and Cavg is the average plasma concentration at steady state.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Terminal Elimination Rate Constant (λz) for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Days 1 and 7
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Apparent Clearance (CL/F) Pharmacokinetic Parameter for TAK-438
Time frame: Days 1 and 7
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
Apparent Volume of Distribution (Vz/F) for TAK-438
Time frame: Days 1 and 7
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.
Ae(0-t): Total Amount of Drug Excreted in Urine from Time 0 to Time T for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Day 1 and Day 7
Ae(0-t) is the total amount of drug excreted in urine from time 0 to t, where t is 24 hours on Day 1 and 48 hours on Day 7.
Ae(0-tau): Total Amount of Drug Excreted in Urine from Time 0 to Time tau for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Day 1 and Day 7
Ae(0-tau) is the total amount of drug excreted in urine from time 0 to tau, where tau equals 24 hours.
Renal Clearance (CLr) for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul
Time frame: Day 1 and Day 7
CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.
Fraction of TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul Excreted in Urine (Fe)
Time frame: Day 1 and Day 7
Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100.
Physical Examination Findings
Time frame: Baseline up to Day 9
A baseline physical examination (defined as the pretreatment assessment immediately prior to the start of study drug) will consist of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; (11) genitourinary system; and (12) other. All subsequent physical examinations should assess clinically significant changes from the baseline examination.
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Time frame: Baseline up to Day 9
Participants with at least one potentially clinically significant post-baseline vital sign finding. Vital signs will include body temperature (oral temperature), sitting blood pressure (after sitting for 5 minutes), and pulse (bpm).
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Baseline to Day 9
Full 12-lead ECGs will be recorded using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (using Bazett correction; QTcB) intervals. The investigator or other qualified physician will interpret each ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Time frame: Baseline up to Day 9
Laboratory tests for hematology, serum chemistries, coagulation tests, and urinalysis will be performed.
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: Baseline up to Day 9
Treatment-emergent 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 through 7 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Safety of TAK-438
Time frame: 3 months
Assessed by physical examination, ECG, and safety tests of blood/urine
Tolerability of TAK-438
Time frame: 3 months
Assessed by adverse events
Pharmacokinetic analysis of plasma TAK-438 concentrations
Time frame: 3 months
Primary pharmacokinetic parameters (AUC (0-tlqc), AUC (0-inf), Cmax) for TAK-438 and its metabolites M-I, M-II, M-III and M-IV-Sul will be subject to statistical analysis
Pharmacodynamic measurement for assay of gastric pH, measurement of gastrin, pepsinogen I, pepsinogen II and the pepsinogen I/II ratio in plasma samples
Time frame: 3 months

7 secondary outcomes

Percentage of Time the pH is Greater than pH 4 and pH 5 over a 24 Hour Period
Time frame: Over a 24-hour period at Baseline and over a 24-hour period following the administration of study on Days 1, 4 and 7
Percentage of Time the pH is Greater than pH 4 and pH 5 over a 48 Hour Period
Time frame: Over a 48-hour period following the administration of study on Day 7
Percentage of Time the PH is Greater than pH 4 and pH 5 from 8 PM to 8 AM
Time frame: Over a 12-hour period from 8 PM to 8 AM on Days 1, 4 and 7
Total Amount of Gastrin in Plasma
Time frame: Predose Days 1 through 7 and Days 8 and 9
Total Amount of Pepsinogen I in Plasma
Time frame: Predose Days 1 through 7 and Days 8 and 9
Total Amount of Pepsinogen II in Plasma
Time frame: Predose Days 1 through 7 and Days 8 and 9
Pepsinogen I/II Ratio in Plasma
Time frame: Predose Days 1 through 7 and Days 8 and 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Derived from this study: PubMed 25707624Jenkins H, Sakurai Y, Nishimura A, Okamoto H, Hibberd M, Jenkins R, Yoneyama T, Ashida K, Ogama Y, Warrington S. Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015 Apr;41(7):636-48. doi: 10.1111/apt.13121. Epub 2015 Feb 23.

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 Clinical Science study director

Takeda

Steve Warrington principal investigator

Hammersmith Medicines Research

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-438 in people with Erosive Esophagitis(EE) and Gastroesophageal Reflux Disease (GERD), run by Takeda at 1 site in United Kingdom.

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 4 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 May 2014. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438 and TAK-438 metabolites M-I, M-II, M-III and M-IV-Sul (time frame: Days 1 and 7). The study lists 25 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 NCT02141711, which also lists 1 linked publication.

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 May 2014.