Dose Finding StudyPhase 1NCT02123953

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Participants

A Phase 1 study testing TAK-438 in people with Dose Finding Study, run by Takeda.

Completed

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

Trial summary

The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438 following multiple oral doses to healthy adult Japanese male participants 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: Dose Finding Study
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: 60 participants
Where: No sites listed yet
Study dates: Oct 2008to Mar 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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult Japanese male volunteer.
Is 20-45 years old inclusive, at time of giving consent.
Is capable of understanding and complying with protocol requirements.
Signs a written, informed consent form prior to the initiation of any study procedure.
Weighs at least 50 kg and has a body mass index (BMI) of 18.5 to 25.0 kg/m^2 inclusive at screening.
Tests negative for hepatitis B surface antigen (HBs), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen-antibody and syphilis serum reaction test.
The participant who the investigator or subinvestigator confirmed to be eligible to participate in this study based on results of the screening tests, and physical examination, physical findings, vital signs, electrocardiogram (ECG), clinical laboratory tests etc. from 3 days before dosing to before the start of dosing on Day 1 with the study drug.

Who cannot join

Has undergone upper gastrointestinal resectioning or vagetomy.
Is judged to have hypoacidity or anacidity.
Presently has or a history of acid-related diseases (e.g., erosive esophagitis, duodenal ulcer, gastric ulcer, non-erosive esophagitis, Barrett's esophagitis or Zollinger-Ellison syndrome).
Received H. pylori eradication treatment within 6 months prior to the start of treatment with the study drug.
Presently has or has a history of hepatic disorder, renal disorder, cardiovascular system disease, blood disease, endocrine disease, metabolic disease, lung disease, gastrointestinal disease, nervous system disease, urological disease, immunological disease or mental illness that makes him not eligible to participate in this study.
Presently has or has a history of hypersensitivity or allergy towards drugs or food.

Show all 17Show 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 treatment with the study drug.
Participant for whom it is difficult to collect blood from the peripheral veins.
Has donated more than 200 mL of whole blood within 4 weeks (28 days) or more than 400 mL of whole blood within 12 weeks (84 days) prior to the start of treatment with the study drug.
Has donated a total volume of more than 800 mL of whole blood within 52 weeks (364 days) prior to the start of treatment with the study drug.
Has given plasma component and plaque component within 2 weeks (14 days) prior to the start of treatment with the study drug.
Has used a prescription drug (including over-the counter drugs) within 4 weeks (28 days) prior to the start of treatment with the study drug.
Has used vitamins, Chinese herbal remedies, or supplement (including St John's Wort, ginseng, kava kava, ginkgo biloba, melatonin) within 4 weeks (28 days) prior to the start of treatment with the study drug.
Has ingested any foods or beverages containing grapefruit (juice or pulp), caffeine, alcohol within 72 hours prior to the start of treatment with the study drug.
Administered another study drug within 16 weeks (112 days) prior to the start of treatment with this study drug.
Administered TAK-438 in the past.
Is considered by the investigator or subinvestigator, for any reason, to be an unsuitable candidate for participating in this study

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Subjects

The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438 following multiple oral doses to healthy adult Japanese male participants

Read the detailed description

The drug being tested in this study is called TAK-438. TAK-438 was being tested to assess side effects and how TAK-438 moves throughout the body after multiple doses have been administered. This study looked at lab results and side effects in people who took TAK-438.

The study consisted of 5 steps covering dose ranges of TAK-438 from 10, 15, 20, 30 and 40 mg once daily for 7 days. The study population for each step included 12 participants. Within each step, 9 participants were randomized to TAK-438 and 3 participants were randomized to placebo. A total of 60 participants were enrolled.

The dosing groups in this study took place in sequential order. Therefore, the TAK-438 15 mg group did not start until the TAK-439 10 mg group had completed, etc. All participants in each dosing group were asked to take the study drug in the morning, after fasting for at least 10 hours, each day throughout the study.

This single-centre trial was conducted in the Japan. The overall time to participate in this study was up to 43 days. Participants made 3 visits to the clinic, including one 11-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.

Conditions: Dose Finding Study
Being tested: TAK-438, TAK-438 Placebo
Keywords: Drug therapy

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 NCT02123953
Study group	Role	What they receive
TAK-438 10 mg	Experimental	TAK-438 10 mg, tablets, orally, once, daily, Days 1 to 7. Receives: Drug: TAK-438
TAK-438 15 mg	Experimental	TAK-438 15 mg, tablets, orally, once, daily, Days 1 to 7. Receives: Drug: TAK-438
TAK-438 20 mg	Experimental	TAK-438 20 mg, tablets, orally, once, daily, Days 1 to 7. Receives: Drug: TAK-438
TAK-438 30 mg	Experimental	TAK-438 30 mg, tablets, orally, once, daily, Days 1 to 7. Receives: Drug: TAK-438
TAK-438 40 mg	Experimental	TAK-438 40 mg, tablets, orally, once, daily, Days 1 to 7. Receives: Drug: TAK-438
Placebo	Placebo comparator	TAK-438 placebo-matching tablets, orally, once, daily, Days 1 to 7. Receives: Drug: TAK-438 Placebo

What is being measured

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

Number of Participants With Adverse Events (AE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows: Mild: The AE was transient and easily tolerated by the participant.
Moderate: The AE caused the participant discomfort and interrupted the participant's usual activities. Severe: The AE caused considerable interference with the participant's usual activities.
Measured: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Vital signs included blood pressure, pulse, respiratory rate, and body temperature (armpit).
Measured: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Changes in Body Weight
Measured: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
The investigator or the subinvestigator interpreted the ECG using 1 of the following categories: "within normal limits", "abnormal but not clinically significant", or "abnormal and clinically significant". The time that the ECG was performed was recorded. The following parameters were recorded from the participant's ECG trace: heart rate, RR interval, PR interval, QT interval, QRS duration, and QTc interval.
Measured: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Laboratory tests for hematology, biochemistry, and urinalysis were be performed.
Measured: Day 1 to Day 15
AUC(0-tau): Area Under the Plasma Concentration-time Curve from Time 0 to Time tau Over the Dosing Interval for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from the time 0 to time tau over a dosing interval, where tau is the length of the dosing interval, 24 hours, calculated using the linear trapezoidal rule.
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
AUC(0-tlqc) is a measure of the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration, calculated using the linear trapezoidal rule.
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUMC(0-tlqc): Area Under the First Moment Plasma Concentration-time Curve from Time 0 (t1) to Time of the Last Quantifiable Concentration (tlqc) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
AUMC(0-tlqc) is a measure of the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
MRT(0-tlqc): Mean Residence Time from Time 0 (t1) to Time of the Last Quantifiable Concentration (tlqc) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
MRT(0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT(0-tlqc)=AUMC(0-tlqc)/AUC(0-tlqc).
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-438F and TAK-438F metabolites M-I and 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 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time to reach the maximum plasma concentration (Tmax), equal to time (hours) to Cmax.
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 to infinity.
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Terminal Elimination Rate Constant (λz) for TAK-438F and TAK-438F metabolites M-I and 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 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Terminal Elimination Half-life (T1/2) for TAK-438F and TAK-438F metabolites M-I and 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 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Apparent Clearance (CL/F) for TAK-438F
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 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Apparent Volume of Distribution (Vz/F) for TAK-438F
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 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUMC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
AUMC(0-inf) is a measure of the area under the first moment plasma concentration-time curve from time 0 to infinity.
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
MRT: Mean Residence Time for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Mean residence time, calculated as MRT=AUMC(0-inf)/AUC(0-inf)
Measured: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Cumulative Urinary Excretion Ratio for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
The cumulative urinary excretion ratio is defined as the percentage of the dose excreted in the urine.
Measured: Days 1 predose, and Days 1 and 7 0-6, 6-12, and 12-24 hours post-dose

Secondary outcomes (5)

24-Hour Intragastric pH Profile
To obtain intragastric pH a portable pH measuring device with a miniature glass electrode that was calibrated using standard pH 4 and pH 7 solutions was placed in the stomach transnasally and its positioned confirmed by X-ray guidance. pH data was recorded electronically 8:30 AM to 9:10 AM of the following day every 10 seconds.
Measured: Day 1 and Day 7
Total Amount of Serum Gastrin
Measured: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15
Total Amount of Serum Pepsinogens I
Measured: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15
Total Amount of Serum Pepsinogens II
Measured: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15
Pepsinogens I/Pepsinogens II Ratio
Measured: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15

Timeline

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

Oct 2008Mar 2009

First posted28 Apr 2014 (estimated)
Study startOct 2008
Primary completionMar 2009
Study completionMar 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 Dose Finding StudyStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02123953
Sponsor's protocol ID: TAK-438/CPH-002
Other IDs: U1111-1153-6907
Status last verified: Apr 2014
First submitted: 24 Apr 2014
Last updated: 28 Apr 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

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?

Official record

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A Phase I Dose Finding Study of MB-CART2219.1
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A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
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All Dose Finding Study trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02123953
Acronym / sponsor ID: TAK-438/CPH-002
Conditions: Dose Finding Study
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 28 Apr 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.

The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438 following multiple oral doses to healthy adult Japanese male participants

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
TAK-438 10 mg	Experimental	Drug: TAK-438TAK-438 10 mg, tablets, orally, once, daily, Days 1 to 7.
TAK-438 15 mg	Experimental	Drug: TAK-438TAK-438 15 mg, tablets, orally, once, daily, Days 1 to 7.
TAK-438 20 mg	Experimental	Drug: TAK-438TAK-438 20 mg, tablets, orally, once, daily, Days 1 to 7.
TAK-438 30 mg	Experimental	Drug: TAK-438TAK-438 30 mg, tablets, orally, once, daily, Days 1 to 7.
TAK-438 40 mg	Experimental	Drug: TAK-438TAK-438 40 mg, tablets, orally, once, daily, Days 1 to 7.
Placebo	Placebo comparator	Drug: TAK-438 PlaceboTAK-438 placebo-matching tablets, orally, once, daily, Days 1 to 7.

Who may qualify

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

Key inclusion criteria (7 listed)

Healthy adult Japanese male volunteer.
Is 20-45 years old inclusive, at time of giving consent.
Is capable of understanding and complying with protocol requirements.
Signs a written, informed consent form prior to the initiation of any study procedure.
Weighs at least 50 kg and has a body mass index (BMI) of 18.5 to 25.0 kg/m^2 inclusive at screening.

Key exclusion criteria (17 listed)

Has undergone upper gastrointestinal resectioning or vagetomy.
Is judged to have hypoacidity or anacidity.
Presently has or a history of acid-related diseases (e.g., erosive esophagitis, duodenal ulcer, gastric ulcer, non-erosive esophagitis, Barrett's esophagitis or Zollinger-Ellison syndrome).
Received H. pylori eradication treatment within 6 months prior to the start of treatment with the study drug.
Presently has or has a history of hepatic disorder, renal disorder, cardiovascular system disease, blood disease, endocrine disease, metabolic disease, lung disease, gastrointestinal disease, nervous system disease, urological disease, immunological disease or mental illness that makes him not eligible to participate in this study.

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	TAK-438 10 mg, TAK-438 15 mg, TAK-438 20 mg, TAK-438 30 mg, TAK-438 40 mg
TAK-438 PlaceboTAK-438 placebo-matching tablets	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events (AE)
Time frame: Day 1 to Day 15
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows: Mild: The AE was transient and easily tolerated by the participant. Moderate: The AE caused the participant discomfort and interrupted the participant's usual activities. Severe: The AE caused considerable interference with the participant's usual activities.
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Time frame: Day 1 to Day 15
Vital signs included blood pressure, pulse, respiratory rate, and body temperature (armpit).
Number of Participants With Potentially Clinically Significant Changes in Body Weight
Time frame: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Day 1 to Day 15
The investigator or the subinvestigator interpreted the ECG using 1 of the following categories: "within normal limits", "abnormal but not clinically significant", or "abnormal and clinically significant". The time that the ECG was performed was recorded. The following parameters were recorded from the participant's ECG trace: heart rate, RR interval, PR interval, QT interval, QRS duration, and QTc interval.
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Time frame: Day 1 to Day 15
Laboratory tests for hematology, biochemistry, and urinalysis were be performed.
AUC(0-tau): Area Under the Plasma Concentration-time Curve from Time 0 to Time tau Over the Dosing Interval for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from the time 0 to time tau over a dosing interval, where tau is the length of the dosing interval, 24 hours, calculated using the linear trapezoidal rule.
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUC(0-tlqc) is a measure of the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration, calculated using the linear trapezoidal rule.
AUMC(0-tlqc): Area Under the First Moment Plasma Concentration-time Curve from Time 0 (t1) to Time of the Last Quantifiable Concentration (tlqc) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUMC(0-tlqc) is a measure of the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
MRT(0-tlqc): Mean Residence Time from Time 0 (t1) to Time of the Last Quantifiable Concentration (tlqc) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
MRT(0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT(0-tlqc)=AUMC(0-tlqc)/AUC(0-tlqc).
Cmax: Maximum Observed Plasma Concentration for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Time to reach the maximum plasma concentration (Tmax), equal to time (hours) to Cmax.
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 to infinity.
Terminal Elimination Rate Constant (λz) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Terminal Elimination Half-life (T1/2) for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
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) for TAK-438F
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
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-438F
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
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.
AUMC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
AUMC(0-inf) is a measure of the area under the first moment plasma concentration-time curve from time 0 to infinity.
MRT: Mean Residence Time for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 to 7 predose, Days 1 and 7 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours post- dose, and Day 7 24 hours post-dose
Mean residence time, calculated as MRT=AUMC(0-inf)/AUC(0-inf)
Cumulative Urinary Excretion Ratio for TAK-438F and TAK-438F metabolites M-I and M-II, M-III and M-IV-Sul
Time frame: Days 1 predose, and Days 1 and 7 0-6, 6-12, and 12-24 hours post-dose
The cumulative urinary excretion ratio is defined as the percentage of the dose excreted in the urine.

5 secondary outcomes

24-Hour Intragastric pH Profile
Time frame: Day 1 and Day 7
Total Amount of Serum Gastrin
Time frame: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15
Total Amount of Serum Pepsinogens I
Time frame: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15
Total Amount of Serum Pepsinogens II
Time frame: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15
Pepsinogens I/Pepsinogens II Ratio
Time frame: Predose Days 1 to 7, Day 7 24 hours post-dose, and Day 15

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 28 Apr 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.

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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.

Medical Director Clinical Science study director

Takeda

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-438 in people with Dose Finding Study, run by Takeda.

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 17 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of Participants With Adverse Events (AE) (time frame: Day 1 to Day 15). The study lists 19 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 NCT02123953, 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 28 Apr 2014.