NCT03849690

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

June 15, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

February 20, 2019

Results QC Date

March 17, 2020

Last Update Submit

May 27, 2021

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

  • Cmax: Maximum Observed Plasma Concentration for TAK-906

    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

    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

    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

    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

    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)

    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

    Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)

Study Arms (1)

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.

Drug: TAK-906Drug: Esomeprazole

Interventions

TAK-906DRUG

TAK-906 capsules.

Also known as: TAK-906 maleate
TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg
EsomeprazoleDRUG

Esomeprazole capsules.

Also known as: Nexium
TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Publications (1)

  • 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.

    PMID: 35218604DERIVED

MeSH Terms

Interventions

trazpirobenEsomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director

    Millennium Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

February 27, 2019

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

June 15, 2021

Results First Posted

May 12, 2020

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

US(1)