A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein

NCT ID: NCT03773068

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2019-08-12

Brief Summary

The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to pharmacokinetics (this is called relative bioavailability). The effect of a meal on the pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally, it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated.

Conditions

Biological Availability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1 - BAY1817080 Dose 1

Participants will receive one single oral dose of BAY1817080 - Formulation B at dose 1 under fasted condition

Group Type: EXPERIMENTAL

BAY1817080 - Formulation B

Intervention Type: DRUG

Formulation B

Group 2 - BAY1817080 Dose 2

Participants will receive a) one single oral dose of BAY1817080 - Formulation A at dose 2 with moderate-fat, moderate-calorie meal (MF, MC); b) one single oral dose of BAY1817080 - Formulation B at dose 2 along with one intravenous (i.v.) infusion of 0.1 mg \[13C715N\]-BAY1817080; and c) one single oral dose of BAY1817080 - Formulation B at dose 2 with high-fat, high-calorie meal (HF, HC). The 3 treatments will be administered with a randomized sequence

Group Type: EXPERIMENTAL

BAY1817080 - Formulation A

Intervention Type: DRUG

Formulation A

BAY1817080 - Formulation B

Intervention Type: DRUG

Formulation B

[13C715N]-BAY 181708 stable isotope label (SIL)

Intervention Type: DRUG

0.1 mg \[13C715N\]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B

Group 3 - BAY1817080 Dose 3

Participants will receive a) one single oral dose of BAY1817080 - Formulation B at dose 3 under fasted condition; followed by one single oral dose of BAY1817080 - Formulation A at dose 3 with MF, MC; and followed by one single oral dose of BAY1817080 - Formulation B at dose 3 with HF, HC. The 3 treatments will be administered with a fixed sequence

Group Type: EXPERIMENTAL

BAY1817080 - Formulation A

Intervention Type: DRUG

Formulation A

BAY1817080 - Formulation B

Intervention Type: DRUG

Formulation B

Interventions

BAY1817080 - Formulation A

Formulation A

Intervention Type: DRUG

BAY1817080 - Formulation B

Formulation B

Intervention Type: DRUG

[13C715N]-BAY 181708 stable isotope label (SIL)

0.1 mg \[13C715N\]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subject
• Age: 18 to 55 years (inclusive) at the time of informed consent and first dose of study medication
• Body mass index (BMI) above/equal to 18 and below/equal to 30 kg/m^2 at Screening
• Body weight of at least 45 kg at Screening

Exclusion Criteria

• Presence or history of clinically relevant cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash
• Known hypersensitivity to the study drugs
• Known severe allergies or significant non-allergic drug reactions
• Febrile illness within 1 week before study drug administration
• Current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs
• Subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Screening
• Poor peripheral venous access
• Regular use of medicines within 6 months prior to screening
• Clinically relevant findings in the electrocardiogram (ECG), physical examination or laboratory examination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PRAHealthSciences

Groningen, , Netherlands

Countries

Netherlands

References

Francke K, Chattopadhyay N, Klein S, Rottmann A, Krickau D, van de Wetering J, Friedrich C. Preclinical and Clinical Pharmacokinetics and Bioavailability in Healthy Volunteers of a Novel Formulation of the Selective P2X3 Receptor Antagonist Eliapixant. Eur J Drug Metab Pharmacokinet. 2023 Jan;48(1):75-87. doi: 10.1007/s13318-022-00805-5. Epub 2022 Dec 5.

Reference Type: DERIVED

PMID: 36469250 (View on PubMed)

Other Identifiers

2018-001814-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19519

Identifier Type: -

Identifier Source: org_study_id