Overview

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

Status:
Completed
Trial end date:
2019-11-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Treatments:
Rifampin
Criteria
Inclusion Criteria:

1. 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.

2. 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.

3. Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs, or ECGs, as deemed by the investigator
or designee.

Exclusion Criteria:

1. Positive urine drug or alcohol results at screening and each check in.

2. Positive urine cotinine at screening.

3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), or hepatitis C virus (HCV).

4. 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.

5. Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.

6. 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.

7. Donation of blood or significant blood loss (example, approximately 500 milliliter
[mL]) within 56 days prior to the first dosing.

8. Plasma donation within 7 days prior to the first dosing.