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NCT Number: NCT04252300

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

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.

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Key information

Conditions

Drug Interactions Chronic Cough Cough Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Rosuvastatin

Drug

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

Other names: Crestor®

Rosuvastatin + BAY1817080

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.

Other names: P2X3 receptor antagonist;, Crestor®

Primary outcomes

  1. Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax)

    Time frame: 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

  2. Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1)

    Time frame: 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

  3. Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC)

    Time frame: 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

  4. Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1)

    Time frame: 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 outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 10 weeks

  2. Severity of treatment-emergent adverse events

    Time frame: Up to 10 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Mar 11, 2021

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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