Status:
COMPLETED
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
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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.
Detailed Description
The drug being tested in this study is called TAK-906. TAK-906 is being tested to evaluate the effect of single dose intravenous rifampin on the single-dose PK of oral TAK-906 in healthy adult partici...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04121078
Start Date
October 15 2019
End Date
November 16 2019
Last Update
December 9 2020
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502