Ascending Single Dose StudyPhase 1NCT02123927

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

A Phase 1 study testing TAK-438 in people with Ascending Single Dose 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 primary purpose of this study was to evaluate the single dose safety and pharmacokinetics of TAK-438 in healthy Japanese men. 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: Ascending Single Dose 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: 108 participants
Where: No sites listed yet
Study dates: Sep 2007to Dec 2007
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

Japanese healthy adult male volunteer.
Is between 20 and 45 years old when giving their informed consent.
Is able to understand the consents of the study and to follow them.
Provides their written informed consent prior to their participation in this study.
Weighs at least 50 kg and has a body mass index (BMI) of 18.5 to 25.0 kg/m^2 at screening.
Has negative results for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, and serological tests for syphilis.
Participant whom the investigator or subinvestigator judged to be eligible on the basis of subjective symptoms, objective findings, vital signs, electrocardiogram (ECG) findings, and results of laboratory tests obtained until before the study drug administration.

Who cannot join

Has undergone upper gastrointestinal resectioning or vagotomy.
Has hypoacidity or anacidity: intragastric pH ≥ 5.5 at X-ray fluoroscopic confirmation of detained position of a pH probe inserted to measure baseline intragastric pH values.
Has a history of previous and current acid-related diseases including reflux esophagitis, gastric ulcer, duodenal ulcer, non-erosive gastroesophageal reflux disease, Barrett's esophagitis or Zollinger-Ellison syndrome.
Is undergoing H. pylori eradication within 6 months before the initiation of the study drug administration.
Has an inappropriate history of previous and current diseases for study participation including hepatic or renal disorders, and cardiovascular, hematological, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, immunological, or psychological diseases.
Has a history of drug and food allergy.

Show all 16Show fewer

Has a history of illegal drug abuse or alcoholism within 5 years before the initiation of the study drug administration.
Has peripheral vessels being difficult.
Has undergone whole blood drawing of at least 200 mL within 4 weeks or 400 mL within 12 weeks prior to initiation of the study drug administration.
Has undergone whole blood drawing of at least 800 mL in total within 52 weeks prior to initiation of the study drug administration.
Has undergone apheresis drawing [plasma (including platelet poor plasma or platelet rich plasma) and platelet component collection] within 2 weeks prior to initiation of the study drug administration.
Is taking any prescriptions or over the counter (OTC) drugs within 4 weeks prior to the study drug administration.
Has taken any vitamins, herbal medicines, and supplements including St. John's wort, Ginseng, kava kava, ginkgo biloba, melatonin within 4 weeks prior to initiation of the study drug administration.
Has had grapefruit (juice and pulp), or caffeine- or alcohol-containing foods or drinks within 72 hr prior to initiation of the study drug administration.
Has received other study drugs within 16 weeks prior to initiation of the study drug administration.
Participants whom the investigator or subinvestigator judged to be ineligible for study participation.

About this study

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

The primary purpose of this study was to evaluate the single dose safety and pharmacokinetics of TAK-438 in healthy Japanese men.

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 and to assess how TAK-438 moves throughout the body. This study will look at lab results and side effects in people who took TAK-438. This study consisted of 2 sequential studies: a single rising dose study (Steps 1 to 7) and a food-effect study (Steps 8 and 9).

The study population for Steps 1 to 7 consisted of 12 participants; with 9 participants randomized to receive a single dose of TAK-438, and 3 participants to receive placebo. Participants in Steps 1 to 7 received a single dose of study drug after a 10-hour fast. The starting dose was 1 mg followed by administrations of 5, 10, 20, 40, 80, and 120 mg. Steps 8 and 9 consisted of 12 participants in a 2-sequence, 2-period crossover design. Four participants were to receive a single dose of TAK-438 and 2 participants were to receive a single dose of placebo on Day 1, in the fasted state, and 4 participants were to receive a single dose of TAK-438 and 2 participants were to receive a single dose of placebo on Day 1 in the fed state, followed by a second single dose of TAK-438 or placebo in the alternative fed state after a 13 day minimum washout period. Participants in Steps 8 randomized to receive TAK-438 will receive 10 mg and participants in Step 9 will receive 40 mg.

This single-centre trial was conducted in Japan. The overall time to participate in this study was up to 32 days depending on the Step assignment. Participants made 3 to 5 visits to the clinic, including one or two 8-day periods of confinement to the clinic, also depending on Step assignment. All participants made a final visit 15 days after last dose of study drug for a follow-up assessment.

Conditions: Ascending Single Dose Study
Being tested: 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
PlaceboDrug
TAK-438 placebo-matching tablets

Study groups in NCT02123927
Study group	Role	What they receive
Step 1: TAK-438 1 mg	Experimental	TAK-438 1 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Step 2: TAK-438 5 mg	Experimental	TAK-438 5 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Step 3: TAK-438 10 mg	Experimental	TAK-438 10 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Step 4: TAK-438 20 mg	Experimental	TAK-438 20 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Step 5: TAK-438 40 mg	Experimental	TAK-438 40 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Step 6: TAK-438 80 mg	Experimental	TAK-438 80 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Step 7: TAK-438 120 mg	Experimental	TAK-438 120 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-438
Steps 1-7: Placebo	Placebo comparator	TAK-438 placebo-matching tablets, orally, once on Day 1. Receives: Drug: Placebo
Step 8A: TAK-438 10 mg	Experimental	TAK-438 10 mg, tablets, orally, under fasted conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 10 mg, tablets, orally, under fed conditions, once on Day 1, Period 2. Receives: Drug: TAK-438
Step 8 B: TAK-438 10 mg	Experimental	TAK-438 10 mg, tablets, orally, under fed conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 10 mg, tablets, orally, under fasted conditions, once on Day 1, Period 2. Receives: Drug: TAK-438
Step 9A: TAK-438 40 mg	Experimental	TAK-438 40 mg, tablets, orally, under fasted conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 40 mg, tablets, orally, under fed conditions, once on Day 1, Period 2. Receives: Drug: TAK-438
Step 9B: TAK-438 40 mg	Experimental	TAK-438 40 mg, tablets, orally, under fed conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 40 mg, tablets, orally, under fasted conditions, once on Day 1, Period 2. Receives: Drug: TAK-438
Steps 8 (A & B) and 9 (A & B): Placebo	Placebo comparator	TAK-438 placebo-matching tablets, orally, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 placebo-matching tablets, orally, once on Day 1, Period 2. Receives: Drug: Placebo

What is being measured

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

Number of Participants With Treatment-Emergent Adverse Events (AE)
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 14 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: Day 1 to Day 15
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 included blood pressure, pulse, respiratory rate, and body temperature (armpit), body weight, and body mass index (BMI).
Measured: Day 1 to Day 15
Change from Baseline in Body Weight
Measured: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Measured: Day 1 to Day 15
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Laboratory tests for hematology, biochemistry, coagulation and urinalysis were be performed.
Measured: Day 1 to Day 15
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to hour 48 for TAK-438 and TAK-438 metabolites M-I and M-II
AUC(0-48) is a measure of the area under the plasma concentration-time curve from time 0 to 48 hours, calculated using the linear trapezoidal rule.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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 and M-II
(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: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
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: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
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: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
Cmax: Maximum Observed Plasma Concentration TAK-438F and TAK-438F metabolites M-I and M-II
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and TAK-438F metabolites M-I and M-II
Time to reach the maximum plasma concentration (Tmax), equal to time (hours) to Cmax.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
Terminal Elimination Rate Constant (λz) for TAK-438F and TAK-438F metabolites M-I and M-II
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
Terminal Elimination Half-life (T1/2) for TAK-438F and TAK-438F metabolites M-I and M-II
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
Apparent Clearance (CL/F) Pharmacokinetic Parameter 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: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
AUMC(0-inf) is a measure of the area under the first moment plasma concentration-time curve from time 0 to infinity, calculated as AUMC(0-tlqc) + lqc x tlqc/λz + lqc/λz^2.
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
MRT: Mean Residence Time for TAK-438F and TAK-438F metabolites M-I and M-II
Mean residence time, calculated as MRT=AUMC(0-inf)/AUC(0-inf).
Measured: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
Cumulative Urinary Excretion Ratio for TAK-438F and TAK-438F metabolites M-I and M-II
The cumulative urinary excretion ratio is defined as the percentage of the dose excreted in the urine.
Measured: Day 1 predose and 0-6, 6-12, 12-24, 24-36 and 36-48 hours postdose

Secondary outcomes (4)

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: Baseline and Day 1
Total Amount of Serum Gastrin
Measured: Baseline at prospective time of dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post prospective dose and Day 1 predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours postdose
Total Amount of Serum Pepsinogen I
Measured: Baseline at prospective time of dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post prospective dose and Day 1 predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours postdose
Total Amount of Serum Pepsinogen Ii
Measured: Baseline at prospective time of dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post prospective dose and Day 1 predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours postdose

Timeline

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

Sep 2007Dec 2007

First posted28 Apr 2014 (estimated)
Study startSep 2007
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ascending Single Dose 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: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02123927
Sponsor's protocol ID: TAK-438/CPH-001
Other IDs: U1111-1153-7002
Status last verified: Apr 2014
First submitted: 24 Apr 2014
Last updated: 28 Apr 2014
Results posted: No
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?

Official record

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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 Single Dose Study of the Safety, Tolerability and Pharmacokinetics of TAK-438 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02123927
Acronym / sponsor ID: TAK-438/CPH-001
Conditions: Ascending Single Dose Study
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (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 primary purpose of this study was to evaluate the single dose safety and pharmacokinetics of TAK-438 in healthy Japanese men.

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: 13

Arm	Type	Receives
Step 1: TAK-438 1 mg	Experimental	Drug: TAK-438TAK-438 1 mg, tablets, orally, once on Day 1.
Step 2: TAK-438 5 mg	Experimental	Drug: TAK-438TAK-438 5 mg, tablets, orally, once on Day 1.
Step 3: TAK-438 10 mg	Experimental	Drug: TAK-438TAK-438 10 mg, tablets, orally, once on Day 1.
Step 4: TAK-438 20 mg	Experimental	Drug: TAK-438TAK-438 20 mg, tablets, orally, once on Day 1.
Step 5: TAK-438 40 mg	Experimental	Drug: TAK-438TAK-438 40 mg, tablets, orally, once on Day 1.
Step 6: TAK-438 80 mg	Experimental	Drug: TAK-438TAK-438 80 mg, tablets, orally, once on Day 1.
Step 7: TAK-438 120 mg	Experimental	Drug: TAK-438TAK-438 120 mg, tablets, orally, once on Day 1.
Steps 1-7: Placebo	Placebo comparator	Drug: PlaceboTAK-438 placebo-matching tablets, orally, once on Day 1.
Step 8A: TAK-438 10 mg	Experimental	Drug: TAK-438TAK-438 10 mg, tablets, orally, under fasted conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 10 mg, tablets, orally, under fed conditions, once on Day 1, Period 2.
Step 8 B: TAK-438 10 mg	Experimental	Drug: TAK-438TAK-438 10 mg, tablets, orally, under fed conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 10 mg, tablets, orally, under fasted conditions, once on Day 1, Period 2.
Step 9A: TAK-438 40 mg	Experimental	Drug: TAK-438TAK-438 40 mg, tablets, orally, under fasted conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 40 mg, tablets, orally, under fed conditions, once on Day 1, Period 2.
Step 9B: TAK-438 40 mg	Experimental	Drug: TAK-438TAK-438 40 mg, tablets, orally, under fed conditions, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 40 mg, tablets, orally, under fasted conditions, once on Day 1, Period 2.
Steps 8 (A & B) and 9 (A & B): Placebo	Placebo comparator	Drug: PlaceboTAK-438 placebo-matching tablets, orally, once on Day 1, Period 1, followed by a 13 day washout period, followed by TAK-438 placebo-matching tablets, orally, once on Day 1, Period 2.

Who may qualify

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

Key inclusion criteria (7 listed)

Japanese healthy adult male volunteer.
Is between 20 and 45 years old when giving their informed consent.
Is able to understand the consents of the study and to follow them.
Provides their written informed consent prior to their participation in this study.
Weighs at least 50 kg and has a body mass index (BMI) of 18.5 to 25.0 kg/m^2 at screening.

Key exclusion criteria (16 listed)

Has undergone upper gastrointestinal resectioning or vagotomy.
Has hypoacidity or anacidity: intragastric pH ≥ 5.5 at X-ray fluoroscopic confirmation of detained position of a pH probe inserted to measure baseline intragastric pH values.
Has a history of previous and current acid-related diseases including reflux esophagitis, gastric ulcer, duodenal ulcer, non-erosive gastroesophageal reflux disease, Barrett's esophagitis or Zollinger-Ellison syndrome.
Is undergoing H. pylori eradication within 6 months before the initiation of the study drug administration.
Has an inappropriate history of previous and current diseases for study participation including hepatic or renal disorders, and cardiovascular, hematological, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, immunological, or psychological diseases.

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	Step 1: TAK-438 1 mg, Step 2: TAK-438 5 mg, Step 3: TAK-438 10 mg, Step 4: TAK-438 20 mg, Step 5: TAK-438 40 mg, Step 6: TAK-438 80 mg, Step 7: TAK-438 120 mg, Step 8 B: TAK-438 10 mg, Step 8A: TAK-438 10 mg, Step 9A: TAK-438 40 mg, Step 9B: TAK-438 40 mg
PlaceboTAK-438 placebo-matching tablets	Drug	Steps 1-7: Placebo, Steps 8 (A & B) and 9 (A & B): Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AE)
Time frame: Day 1 to Day 15
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 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Time frame: Day 1 to Day 15
Participants with at least one potentially clinically significant post-baseline vital sign finding. Vital signs included blood pressure, pulse, respiratory rate, and body temperature (armpit), body weight, and body mass index (BMI).
Change from Baseline 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
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Time frame: Day 1 to Day 15
Laboratory tests for hematology, biochemistry, coagulation and urinalysis were be performed.
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to hour 48 for TAK-438 and TAK-438 metabolites M-I and M-II
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
AUC(0-48) is a measure of the area under the plasma concentration-time curve from time 0 to 48 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-438 and TAK-438 metabolites M-I and M-II
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
(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]).
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
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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 TAK-438F and TAK-438F metabolites M-I and M-II
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Terminal Elimination Rate Constant (λz) for TAK-438F and TAK-438F metabolites M-I and M-II
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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-438F
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
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
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
AUMC(0-inf) is a measure of the area under the first moment plasma concentration-time curve from time 0 to infinity, calculated as AUMC(0-tlqc) + lqc x tlqc/λz + lqc/λz^2.
MRT: Mean Residence Time for TAK-438F and TAK-438F metabolites M-I and M-II
Time frame: Day 1 predose (0 hours) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours postdose
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
Time frame: Day 1 predose and 0-6, 6-12, 12-24, 24-36 and 36-48 hours postdose
The cumulative urinary excretion ratio is defined as the percentage of the dose excreted in the urine.

4 secondary outcomes

24-Hour Intragastric pH Profile
Time frame: Baseline and Day 1
Total Amount of Serum Gastrin
Time frame: Baseline at prospective time of dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post prospective dose and Day 1 predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours postdose
Total Amount of Serum Pepsinogen I
Time frame: Baseline at prospective time of dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post prospective dose and Day 1 predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours postdose
Total Amount of Serum Pepsinogen Ii
Time frame: Baseline at prospective time of dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post prospective dose and Day 1 predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours postdose

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.

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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 Ascending Single Dose 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 16 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 Treatment-Emergent Adverse Events (AE) (time frame: Day 1 to Day 15). The study lists 18 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 NCT02123927.

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.