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

NCT04252300 | Completed Phase 1 FDA Drug

• 1 other identifier: 20246
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

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

  Up to 10 weeks

• Severity of treatment-emergent adverse events

  Up to 10 weeks

Study Arms (2)

Healthy subjects_Period 1

EXPERIMENTAL

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

Drug: Rosuvastatin

Healthy subjects_Period 2

EXPERIMENTAL

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

Drug: Rosuvastatin + BAY1817080

Interventions

Rosuvastatin DRUG

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

Also known as: Crestor®

Healthy subjects_Period 1

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.

Also known as: P2X3 receptor antagonist;, Crestor®

Healthy subjects_Period 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Pain; Chronic Cough

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: March 2, 2020
• Primary Completion: August 29, 2020
• Study Completion: December 7, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

US (1)