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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT04252300

Collaborator

(none)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Interactions	Drug: Rosuvastatin Drug: Rosuvastatin + BAY1817080	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Open Label, Fixed Sequences, One-way Cross-over Study to Determine the Effects of Multiple Doses BAY1817080 (150 mg) on the Pharmacokinetics of a 5 mg Dose Rosuvastatin in Healthy Participants

Actual Study Start Date :

Mar 2, 2020

Actual Primary Completion Date :

Aug 29, 2020

Actual Study Completion Date :

Dec 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy subjects_Period 1 Healthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1.	Drug: Rosuvastatin Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days). Other Names: Crestor®
Experimental: Healthy subjects_Period 2 The healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2.	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. Other Names: P2X3 receptor antagonist; Crestor®

Arm

Intervention/Treatment

Experimental: Healthy subjects_Period 1

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

Drug: Rosuvastatin

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

Other Names:

Crestor®

Experimental: Healthy subjects_Period 2

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

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.

Other Names:

P2X3 receptor antagonist;

Crestor®

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax) [Predose and up to 15 hours after drug on Day 1, 0 and 12 hours on Day 2, 0 hours on Day 3, 4 and 5 of Period 1]
Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1) [Predose and up to 15 hours after rosuvastatin on Day 8, 0 and 12 hours on Day 9, 0 hour on Days 10, 11, 12, 13, 14 and 15 of Period 2]
Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC) [Predose and up to 15 hours after drug on Day 1, 0 and 12 hours on Day 2, 0 hours on Day 3, 4 and 5 of Period 1]
Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1) [Predose and up to 15 hours after rosuvastatin on Day 8, 0 and 12 hours on Day 9, 0 hour on Days 10, 11, 12, 13, 14 and 15 of Period 2]

Secondary Outcome Measures

Number of participants with treatment-emergent adverse events (TEAEs) [Up to 10 weeks]
Severity of treatment-emergent adverse events [Up to 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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