Clinical trial NCT03773068: 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
Official title: Open Label, Partially Randomized, Cross-over Study to Determine the Absolute Bioavailability and Pharmacokinetics of BAY1817080 Using a Simultaneous Anticipated Therapeutic Oral Dose Along With an i.v. [13C715N]-Labeled Microtracer and to Investigate the Relative Bioavailability of Two Formulations Given Under Different Diets at 2 Dose Levels in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Biological Availability
Keywords: Endometriosis
Refractory chronic cough
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-12-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Absolute oral bioavailability (F) of BAY1817080
timeFrame: Up to 10 days
measure: Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets
timeFrame: Up to 10 days
Secondary outcomes:
measure: Effect of a high-fat, high-calorie meal (HF,HC) on the PK of BAY1817080 after a single oral dose of Formulation B at two doses in comparison to the fasted state evaluated by Cmax
timeFrame: Up to 10 days
measure: Effect of a high-fat, high-calorie meal (HF,HC) on the PK of BAY1817080 after a single oral dose of Formulation B at two doses in comparison to the fasted state evaluated by AUC
timeFrame: Up to 10 days
measure: Dose proportionality in BAY1817080 PK after a single oral dose of Formulation B across three doses in fasted state evaluated by Cmax/D
timeFrame: Up to 10 days
measure: Dose proportionality in BAY1817080 PK after a single oral dose of Formulation B across three doses in fasted state evaluated by AUC/D
timeFrame: Up to 10 days
measure: Frequency and severity of treatment emergent adverse events (TEAEs)
timeFrame: Up to 42 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRAHealthSciences
Study officials:
References: