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

NCT ID: NCT04121078

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2019-11-16

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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg

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.

Group Type: EXPERIMENTAL

TAK-906

Intervention Type: DRUG

TAK-906 capsule.

Rifampin

Intervention Type: DRUG

Rifampin infusion.

Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg

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.

Group Type: EXPERIMENTAL

TAK-906

Intervention Type: DRUG

TAK-906 capsule.

Rifampin

Intervention Type: DRUG

Rifampin infusion.

Interventions

TAK-906

TAK-906 capsule.

Intervention Type: DRUG

Rifampin

Rifampin infusion.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Celerion

Lincoln, Nebraska, United States

Countries

United States

References

Mukker JK, Dukes G, Tolkoff M, Wang L, Almansa C, Huh SY, Nishihara M, Ramsden D, Chen C. The pharmacokinetics of oral trazpiroben (TAK-906) after organic anion transporting polypeptide 1B1/1B3 inhibition: A phase I, randomized study. Clin Transl Sci. 2022 Jun;15(6):1532-1543. doi: 10.1111/cts.13274. Epub 2022 May 5.

Reference Type: DERIVED

PMID: 35460165 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

U1111-1240-6352

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-906-1009

Identifier Type: -

Identifier Source: org_study_id