check_circleStudy Completed

Drug Interactions

Bayer Identifier:

20246

ClinicalTrials.gov Identifier:

NCT04252300

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to learn the effect of drug BAY1817080 on the way the body absorbs, distributes and excretes another drug rosuvastatin in healthy adult participants

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 55 Years
  • - 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

  • - 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

Trial summary

Enrollment Goal
14
Trial Dates
March 2020 - December 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Covance Clinical Research Unit, Inc.Daytona Beach, 32117, United States

Primary Outcome

  • Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax)
    date_rangeTime 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
  • Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1)
    date_rangeTime 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
  • Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC)
    date_rangeTime 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
  • Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1)
    date_rangeTime 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 Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 10 weeks
  • Severity of treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 10 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2