Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interactions
Keywords: P2X3 receptor antagonist
Rosuvastatin
Organic Anion Transporting Polypeptide 1B1 (OATP1B1)
Organic Anion Transporting Polypeptide 1B3 (OATP1B3)
Breast Cancer Resistance Protein (BCRP)
Pain
Chronic cough
Cholesterol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax)
timeFrame: 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
measure: Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1)
timeFrame: 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
measure: Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC)
timeFrame: 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
measure: Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1)
timeFrame: 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:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to 10 weeks
measure: Severity of treatment-emergent adverse events
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Florida
Study officials:
References: