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Drug InteractionsPhase 1NCT04252300

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

A Phase 1 study testing Rosuvastatin and Rosuvastatin + BAY1817080 in people with Drug Interactions, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Drug Interactions
What is being tested?
Rosuvastatin and Rosuvastatin + BAY1817080
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
2 Mar 2020to 7 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit, Inc.

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Rosuvastatin, Rosuvastatin + BAY1817080
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
Medical subject headings
Pain, Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosuvastatinDrug

    Also called Crestor®

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

  • Rosuvastatin + BAY1817080Drug

    Also called P2X3 receptor antagonist;, Crestor®

    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.

Study groups in NCT04252300
Study groupRoleWhat they receive
Healthy subjects_Period 1ExperimentalHealthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1.
Receives: Drug: Rosuvastatin
Healthy subjects_Period 2ExperimentalThe healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2.
Receives: Drug: Rosuvastatin + BAY1817080

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

    Measured: Up to 10 weeks

  2. Severity of treatment-emergent adverse events

    Measured: Up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start2 Mar 2020
  3. Primary completion29 Aug 2020
  4. Study completion7 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252300
Sponsor's protocol ID
20246
Status last verified
Mar 2021
First submitted
31 Jan 2020
Last updated
11 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rosuvastatin and Rosuvastatin + BAY1817080 in people with Drug Interactions, run by Bayer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04252300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.

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