Healthy VolunteersPhase 1NCT03849690

A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants

A Phase 1 study testing TAK-906 and Esomeprazole in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TAK-906 and Esomeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 27 Feb 2019to 15 Apr 2019
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) at Screening.

Who cannot join

History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
QT interval corrected using Fridericia's formula (QTcF) interval is greater than (>) 450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
Donation of blood or significant blood loss (example, approximately 500 milliliter [mL]) within 56 days prior to the first dosing.
Plasma donation within 7 days prior to the first dosing.
Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30 day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Study Period 1 of the current study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Single-Sequence, Open-Label, 2-Period, Crossover Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects

The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.

Read the detailed description

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.

The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence:

TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg

All participants will be given an oral dose of TAK-906 and Esomeprazole.

This single center trial will be conducted in the United States. The overall duration to participate in this study is 52 days. Participants will make visit to the clinic during Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last dose of TAK-906 for a follow up assessment.

Conditions: Healthy Volunteers
Being tested: TAK-906, Esomeprazole
Keywords: Drug Therapy

What participants receive

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

TAK-906Drug
Also called TAK-906 maleate
TAK-906 capsules.
EsomeprazoleDrug
Also called Nexium
Esomeprazole capsules.

Study groups in NCT03849690
Study group	Role	What they receive
TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg	Experimental	TAK-906 25 milligram (mg), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. Receives: Drug: TAK-906; Drug: Esomeprazole

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-906
Measured: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
Measured: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
Measured: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose

Secondary outcomes (4)

Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs
A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 scales as severe(severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as life-threatening consequences, urgent intervention indicated, and Grade 5 scales as death related to AE.
Measured: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)
Measured: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values
Measured: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)

Timeline

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

27 Feb 201915 Apr 2019

First posted21 Feb 2019
Study start27 Feb 2019
Primary completion15 Apr 2019
Study completion15 Apr 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03849690
Sponsor's protocol ID: TAK-906-1006
Other IDs: U1111-1224-9867
Status last verified: May 2021
First submitted: 20 Feb 2019
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Kaur Mukker J, Dukes G, Wang L, Huh S, Khudyakov P, Nishihara M, Chen C. Evaluation of the pharmacokinetics of trazpiroben (TAK-906) in the presence and absence of the proton pump inhibitor esomeprazole. Clin Transl Sci. 2022 May;15(5):1281-1290. doi: 10.1111/cts.13248. Epub 2022 Feb 26.
PubMed 35218604

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Sequence, Open-Label, 2-Period, Crossover Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT03849690
Acronym / sponsor ID: TAK-906-1006
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 27 Feb 2019 (actual)
Primary completion: 15 Apr 2019 (actual)
Study completion: 15 Apr 2019 (actual)
First posted: 21 Feb 2019 (actual)
Results: Posted 12 May 2020

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 evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.

Detailed description

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.

The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence:

TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg

All participants will be given an oral dose of TAK-906 and Esomeprazole.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg	Experimental	Drug: TAK-906, Drug: EsomeprazoleTAK-906 25 milligram (mg), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) at Screening.

Key exclusion criteria (5 listed)

History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
QT interval corrected using Fridericia's formula (QTcF) interval is greater than (>) 450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
Donation of blood or significant blood loss (example, approximately 500 milliliter [mL]) within 56 days prior to the first dosing.
Plasma donation within 7 days prior to the first dosing.
Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30 day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Study Period 1 of the current 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-906Also: TAK-906 maleateTAK-906 capsules.	Drug	TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg
EsomeprazoleAlso: NexiumEsomeprazole capsules.	Drug	TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose

4 secondary outcomes

Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)

Results and safety

Results posted to the registry on 12 May 2020, 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-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg	12	12

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-906

Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	TAK-906 25 mg n = 12	Esomeprazole 40 mg and TAK-906 25 mg n = 12
Value	19.76 (36.5)	17.24 (40.5)

TAK-906 25 mg vs Esomeprazole 40 mg and TAK-906 25 mg: Geometric mean ratio: 0.87 (90% CI 0.70 to 1.09), p = 0.3011, ANOVA

Population analysed: The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).

Primary outcome: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906

Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	TAK-906 25 mg n = 12	Esomeprazole 40 mg and TAK-906 25 mg n = 12
Value	43.31 (27.8)	37.98 (31.2)

TAK-906 25 mg vs Esomeprazole 40 mg and TAK-906 25 mg: Geometric mean ratio: 0.88 (90% CI 0.77 to 0.99), p = 0.0865, ANOVA

Population analysed: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906

Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	TAK-906 25 mg n = 12	Esomeprazole 40 mg and TAK-906 25 mg n = 12
Value	44.03 (27.5)	38.85 (31.1)

TAK-906 25 mg vs Esomeprazole 40 mg and TAK-906 25 mg: Geometric mean ratio: 0.88 (90% CI 0.78 to 1.00), p = 0.3011, ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-906 25 mg	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Esomeprazole 40 mg	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Esomeprazole 40 mg and TAK-906 25 mg	0 of 12 (0%)	3 of 12 (25%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35218604Kaur Mukker J, Dukes G, Wang L, Huh S, Khudyakov P, Nishihara M, Chen C. Evaluation of the pharmacokinetics of trazpiroben (TAK-906) in the presence and absence of the proton pump inhibitor esomeprazole. Clin Transl Sci. 2022 May;15(5):1281-1290. doi: 10.1111/cts.13248. Epub 2022 Feb 26.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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

Millennium Pharmaceuticals, Inc.

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-906 and Esomeprazole in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 12 May 2020). 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 TAK-906 (time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose). The study lists 3 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 NCT03849690, 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 15 Jun 2021.