Trial Condition(s):

Biological Availability

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

Bayer Identifier:

19519

ClinicalTrials.gov Identifier:

NCT03773068

EudraCT Number:

2018-001814-13

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1817080
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

PRAHealthSciences

GRONINGEN, Netherlands, 9728 NZ

Status
Completed
 

Trial Design