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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252300
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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 : March 2, 2020
Estimated Primary Completion Date : July 19, 2020
Estimated Study Completion Date : September 19, 2020


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 Name: 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®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252300


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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United States, Florida
Covance Clinical Research Unit, Inc. Recruiting
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04252300    
Other Study ID Numbers: 20246
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
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
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors