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
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT04121078
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 12
- Starts
- 2019-10-15
- Expected to finish
- 2019-11-16
- Last updated by the study team
- 2020-12-09
Who can join
Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Celerion — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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