A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
A Phase 1, Open-Label, Randomized, Two-Way Crossover Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of OATP1B1 and OATP1B3 on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects
2 other identifiers
interventional
12
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of single dose intravenous rifampin on the single-dose PK of orally administered TAK-906.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Oct 2019
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2019
CompletedResults Posted
Study results publicly available
December 9, 2020
CompletedDecember 9, 2020
November 1, 2020
20 days
October 8, 2019
November 13, 2020
November 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cmax: Maximum Observed Plasma Concentration for TAK-906
Day 1: time zero and at multiple time points (up to 48 hours) post dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
Day 1: time zero and at multiple time points (up to 48 hours) post dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
Day 1: time zero and at multiple time points (up to 48 hours) post dose
Secondary Outcomes (4)
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Study Arms (2)
Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg
EXPERIMENTALTAK-906 25 milligram (mg) (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2.
Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg
EXPERIMENTALRifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1 followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2.
Interventions
TAK-906 capsule.
Rifampin infusion.
Eligibility Criteria
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.
- Body Mass Index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/ m\^2) at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the investigator or designee.
You may not qualify if:
- Positive urine drug or alcohol results at screening and each check in.
- Positive urine cotinine at screening.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- QT interval with Fridericia's correction (QTcF) interval is \>450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the investigator or designee at screening.
- Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening.
- Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Lincoln, Nebraska, 68502, United States
Related Publications (1)
Mukker JK, Dukes G, Tolkoff M, Wang L, Almansa C, Huh SY, Nishihara M, Ramsden D, Chen C. The pharmacokinetics of oral trazpiroben (TAK-906) after organic anion transporting polypeptide 1B1/1B3 inhibition: A phase I, randomized study. Clin Transl Sci. 2022 Jun;15(6):1532-1543. doi: 10.1111/cts.13274. Epub 2022 May 5.
PMID: 35460165DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 9, 2019
Study Start
October 15, 2019
Primary Completion
November 4, 2019
Study Completion
November 16, 2019
Last Updated
December 9, 2020
Results First Posted
December 9, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- 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.
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.