Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants

NCT ID: NCT04252300

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-12-07

Brief Summary

Researchers in this study want to learn how the study drug BAY1817080 interacts with another drug called rosuvastatin (brand name: Crestor) and affects the way the body absorbs, distributes and excretes rosuvastatin in healthy adult male and female participants (drug-drug interaction study). The study drug BAY1817080 is a new drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins related to pain in the body. Rosuvastatin is an approved and marketed drug to lower high levels of "bad" cholesterol (a waxy, fat-like substance found in blood). Both drugs interact with the same proteins (molecules) in the human body, and as a result, the study drug may affect the way rosuvastatin is taken up and used by the body when applied together.

Participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4 weeks. Each participant will receive rosuvastatin tablets twice with at least 11 days in between and the study drug tablets twice daily for 14 days. Blood samples will be taken from the participants to measure the blood levels of rosuvastatin.

Detailed Description

The primary objective of the study is to investigate the influence of multiple doses of BAY1817080 on the pharmacokinetics of rosuvastatin given concomitantly. Secondary objective is to investigate the safety of BAY1817080.

Conditions

Drug Interactions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy subjects_Period 1

Healthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).

Healthy subjects_Period 2

The healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2.

Group Type: EXPERIMENTAL

Rosuvastatin + BAY1817080

Intervention Type: DRUG

A single dose of 5 mg rosuvastatin tablets is administered on Day 8 of Period 2 (total length = 15 days). BAY1817080 is administered as tablets twice daily on Days 1 to 14 of Period 2.

Interventions

Rosuvastatin

Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).

Intervention Type: DRUG

Rosuvastatin + BAY1817080

A single dose of 5 mg rosuvastatin tablets is administered on Day 8 of Period 2 (total length = 15 days). BAY1817080 is administered as tablets twice daily on Days 1 to 14 of Period 2.

Intervention Type: DRUG

Other Intervention Names

Crestor®; P2X3 receptor antagonist; Crestor®

Eligibility Criteria

Inclusion Criteria

• Participant is healthy as determined by the investigator
• White or Black race
• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m² at screening
• Body weight of at least 50 kg at screening

Exclusion Criteria

• Known or suspected allergy or hypersensitivity to BAY1817080, rosuvastatin or any of their excipients
• Asian race
• Contraindications to rosuvastatin
• Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first study intervention administration or during the study until follow-up (occasional use of ibuprofen is permissible)
• History of or positive COVID-19 test or contact with COVID-19 positive subject in past 4 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit, Inc.

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

20246

Identifier Type: -

Identifier Source: org_study_id