Healthy ParticipantsPhase 1NCT03085836

A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants

A Phase 1 study testing TAK-438 in people with Healthy Participants, run by Takeda at 1 site in China.

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 is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: TAK-438
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteChina
Study dates: 19 Apr 2017to 17 Aug 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

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

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is a healthy adult male or female Chinese participant.
Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).

Who cannot join

Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
Has poor peripheral venous access.
Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Hospital Fudan University
Shanghai, 200032

Other trials in China

About this study

Official title: An Open-Label, Single-center, Parallel, Phase 1 Study to Determine the Pharmacokinetics of Single- and Multiple- Oral Doses of TAK-438 10 mg and 20 mg in Healthy Adult Chinese Subjects

The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.

Read the detailed description

The drug being tested in this study is called TAK-438. TAK-438 is being tested in healthy participants in order to evaluate the PK of single and multiple oral dose.

The study will enroll approximately 36 healthy participants. Participants will be assigned to one of the three treatment groups:

TAK-438 10 mg tablet once daily
TAK-438 20 mg tablet once daily
TAK-438 20 mg tablet twice daily All participants will be asked to take TAK-438 tablet at the same time on Day 1 and Days 3-9.

This single-centre trial will be conducted in China. The overall time to participate in this study is 18 days. Participants will remain confined to the clinic from Day 1 up to Day 11 and will be followed-up by telephone or visit on Day 18.

Conditions: Healthy Participants
Being tested: TAK-438
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.

Study groups in NCT03085836
Study group	Role	What they receive
TAK-438 10 milligram (mg) Once Daily	Experimental	TAK-438 10 mg, tablets, orally, once daily on Days 1, 3-9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment. Receives: Drug: TAK-438
TAK-438 20 mg Once Daily	Experimental	TAK-438 20 mg, tablets, orally, once daily on Days 1, 3-9. Participants were asked to fast for a minimum of 10 hours prior administration of assigned treatment. Receives: Drug: TAK-438
TAK-438 20 mg Twice Daily	Experimental	TAK-438 20 mg, tablets, orally, once on Day 1 and twice daily on Days 3-9. Participants were asked to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner. Receives: Drug: TAK-438

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Measured: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Measured: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Measured: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Measured: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Measured: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Measured: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Measured: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

Timeline

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

19 Apr 201717 Aug 2017

First posted21 Mar 2017
Study start19 Apr 2017
Primary completion17 Aug 2017
Study completion17 Aug 2017

Resources

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

More details

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

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03085836
Sponsor's protocol ID: TAK-438_114
Other IDs: U1111-1191-6949, CTR20170137
Status last verified: Aug 2018
First submitted: 16 Mar 2017
Last updated: 30 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

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

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

Questions to ask the study team

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

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-center, Parallel, Phase 1 Study to Determine the Pharmacokinetics of Single- and Multiple- Oral Doses of TAK-438 10 mg and 20 mg in Healthy Adult Chinese Subjects
ClinicalTrials.gov ID: NCT03085836
Acronym / sponsor ID: TAK-438_114
Conditions: Healthy Participants
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 19 Apr 2017 (actual)
Primary completion: 17 Aug 2017 (actual)
Study completion: 17 Aug 2017 (actual)
First posted: 21 Mar 2017 (actual)
Results: Posted 30 Jan 2019

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 is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.

Detailed description

The drug being tested in this study is called TAK-438. TAK-438 is being tested in healthy participants in order to evaluate the PK of single and multiple oral dose.

The study will enroll approximately 36 healthy participants. Participants will be assigned to one of the three treatment groups:

TAK-438 10 mg tablet once daily
TAK-438 20 mg tablet once daily
TAK-438 20 mg tablet twice daily All participants will be asked to take TAK-438 tablet at the same time on Day 1 and Days 3-9.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TAK-438 10 milligram (mg) Once Daily	Experimental	Drug: TAK-438TAK-438 10 mg, tablets, orally, once daily on Days 1, 3-9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
TAK-438 20 mg Once Daily	Experimental	Drug: TAK-438TAK-438 20 mg, tablets, orally, once daily on Days 1, 3-9. Participants were asked to fast for a minimum of 10 hours prior administration of assigned treatment.
TAK-438 20 mg Twice Daily	Experimental	Drug: TAK-438TAK-438 20 mg, tablets, orally, once on Day 1 and twice daily on Days 3-9. Participants were asked to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.

Who may qualify

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

Key inclusion criteria (6 listed)

Is a healthy adult male or female Chinese participant.
Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.

Key exclusion criteria (5 listed)

Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
Has poor peripheral venous access.
Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.

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 milligram (mg) Once Daily, TAK-438 20 mg Once Daily, TAK-438 20 mg Twice Daily

Primary outcome

Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

Results and safety

Results posted to the registry on 30 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-438 10 mg Once Daily	12	12
TAK-438 20 mg Once Daily	11	11
TAK-438 20 mg Twice Daily	10	10

Primary outcome: Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	TAK-438 10 mg Once Daily n = 12	TAK-438 20 mg Once Daily n = 11	TAK-438 20 mg Twice Daily n = 10
TAK-438F	9.148 (2.9972)	18.18 (4.4973)	25.23 (10.017)
M-I	38.32 (8.6143)	67.95 (23.388)	59.02 (18.443)
M-II	2.840 (1.0442)	5.155 (2.7868)	4.879 (2.2426)
M-III	15.42 (3.7788)	25.63 (7.8650)	25.67 (5.9219)
M-IV-Sul	28.29 (5.0563)	60.67 (16.499)	42.28 (9.1174)

Population analysed: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose. Median (Full Range). Unit: hour

Measure	TAK-438 10 mg Once Daily n = 12	TAK-438 20 mg Once Daily n = 11	TAK-438 20 mg Twice Daily n = 10
TAK-438F	1.750 (1.00 to 4.02)	2.000 (0.750 to 4.00)	2.500 (0.750 to 4.00)
M-I	1.500 (0.750 to 2.00)	1.500 (0.750 to 3.00)	2.000 (1.00 to 4.00)
M-II	4.010 (3.00 to 10.0)	6.000 (3.00 to 10.0)	10.00 (3.00 to 12.0)
M-III	1.750 (1.00 to 2.00)	2.000 (1.50 to 3.00)	2.000 (1.50 to 4.00)
M-IV-Sul	1.500 (1.00 to 2.00)	1.500 (1.50 to 3.00)	2.000 (1.50 to 3.00)

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	TAK-438 10 mg Once Daily n = 12	TAK-438 20 mg Once Daily n = 11	TAK-438 20 mg Twice Daily n = 10
TAK-438F	84.38 (29.197)	188.1 (43.066)	226.8 (67.128)
M-I	305.7 (88.227)	617.2 (213.56)	578.7 (144.15)
M-II	52.97 (22.843)	106.3 (74.306)	117.8 (41.170)
M-III	92.83 (34.769)	178.7 (64.779)	193.7 (56.808)
M-IV-Sul	132.5 (44.602)	307.5 (89.884)	240.8 (82.555)

Primary outcome: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: h*ng/mL

Measure	TAK-438 10 mg Once Daily n = 12	TAK-438 20 mg Once Daily n = 11	TAK-438 20 mg Twice Daily n = 10
TAK-438F	74.91 (24.835)	168.6 (37.455)	154.8 (38.920)
M-I	251.4 (77.758)	528.8 (182.62)	344.1 (91.089)
M-II	31.77 (18.646)	79.07 (56.206)	41.55 (19.189)
M-III	87.98 (31.136)	169.2 (59.474)	149.1 (36.714)
M-IV-Sul	127.1 (43.648)	296.0 (86.359)	192.8 (57.176)

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-438 10 mg Once Daily	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
TAK-438 20 mg Once Daily	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
TAK-438 20 mg Twice Daily	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

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

Medical Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-438 in people with Healthy Participants, run by Takeda at 1 site in China.

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 6 inclusion and 5 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 30 Jan 2019. 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 (time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose). The study lists 14 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 NCT03085836.

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 30 Jan 2019.