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NCT Number: NCT04121078

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

TAK-906

Drug

TAK-906 capsule.

Rifampin

Drug

Rifampin infusion.

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for TAK-906

    Time frame: Day 1: time zero and at multiple time points (up to 48 hours) post dose

  2. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906

    Time frame: Day 1: time zero and at multiple time points (up to 48 hours) post dose

  3. 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: time zero and at multiple time points (up to 48 hours) post dose

Secondary outcomes

  1. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

  2. Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values

    Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

  3. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings

    Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

  4. Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values

    Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Two-Way Crossover Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of OATP1B1 and OATP1B3 on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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