A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OTAP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants

Overview

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.

Full Title of Study: “A Phase 1, Open-Label, Randomized, Two-Way Crossover Trial to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of OATP1B1 and OTAP1B3 on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 4, 2019

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 groups:

- TAK-906 25 mg + Rifampin 600 mg and TAK-906 25 mg

- Rifampin 600 mg and TAK-906 25 mg + 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.

Interventions

  • Drug: TAK-906
    • TAK-906 capsule.
  • Drug: Rifampin
    • Rifampin infusion.

Arms, Groups and Cohorts

  • Experimental: TAK-906 25 mg + Rifampin 600 mg and TAK-906 25 mg
    • TAK-906 25 milligram (mg), 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, capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2.
  • Experimental: Rifampin 600 mg and TAK-906 25 mg + TAK-906 25 mg
    • Rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg, 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, capsule, orally, once on Day 1 of Study Period 2.

Clinical Trial Outcome Measures

Primary Measures

  • Cmax: Maximum Observed Plasma Concentration for TAK-906
    • Time Frame: Day 1 pre-dose 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
    • Time Frame: Day 1 pre-dose 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
    • Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Secondary Measures

  • Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
    • Time Frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 15)
  • Number of Participants with Clinically Significant Change From Baseline in Vital Signs
    • Time Frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 15)
  • Number of Participants with Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
    • Time Frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 15)
  • Number of Participants with Clinically Significant Change From Baseline in Clinical Laboratory Values
    • Time Frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 15)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Millennium Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Millennium Pharmaceuticals, Inc.
  • Overall Contact(s)
    • Takeda Study Registration Call Center, +1-877-825-3327, medicalinformation@tpna.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.