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
- Registration Number
- NCT04121078
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- 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 participants.
The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the two treatment sequences AB or BA:
* Sequence AB: TAK-906 25 mg, followed by a washout period of at least 7 days, then Rifampin 600 mg and TAK-906 25 mg
* Sequence BA: Rifampin 600 mg and TAK-906 25 mg, followed by a washout period of at least 7 days, then TAK-906 25 mg
This single center trial will be conducted in the United States. The overall time to participate in this study is 49 Days. All participants will make final visit 14 days after receiving their last dose of study drug for follow up assessment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg TAK-906 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 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. Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg TAK-906 TAK-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 AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg Rifampin TAK-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 Rifampin 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 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.
- Primary Outcome Measures
Name Time Method 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 Cmax: Maximum Observed Plasma Concentration for TAK-906 Day 1: time zero and at multiple time points (up to 48 hours) post dose
- Secondary Outcome Measures
Name Time Method 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 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 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 Clinical Laboratory Values Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States