Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Biological Availability
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03773068
Start Date
December 13 2018
End Date
August 12 2019
Last Update
August 19 2019
Active Locations (1)
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1
PRAHealthSciences
Groningen, Netherlands, 9728 NZ