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

Biological Availability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773068
• Other study ID #: 19519
• Secondary ID: 2018-001814-13
• Status: Completed
• Phase: Phase 1
• Start date: December 13, 2018
• Est. completion date: August 12, 2019

Study information

• Verified date: August 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 12, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Biological Availability

Intervention

Drug:
• BAY1817080 - Formulation A
Formulation A
• BAY1817080 - Formulation B
Formulation B
• [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

Locations

Country	Name	City	State
Netherlands	PRAHealthSciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute oral bioavailability (F) of BAY1817080		Up to 10 days
Primary	Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets		Up to 10 days
Secondary	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	Maximum observed drug concentration in plasma after single dose administration (Cmax) of BAY1817080 will be analyzed assuming log-normally distributed data.	Up to 10 days
Secondary	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	Area under the concentration versus time curve from zero to infinity after single dose administration (AUC) of BAY1817080 will be analyzed assuming log-normally distributed data. AUC from time 0 to the last data point greater than lower limit of quantification (AUC[0-tlast]) will be used if AUC cannot be calculated reliably in all subjects.	Up to 10 days
Secondary	Dose proportionality in BAY1817080 PK after a single oral dose of Formulation B across three doses in fasted state evaluated by Cmax/D	To investigate dose-proportionality, Cmax divided by dose (Cmax/D) derived from the 3 oral doses of Formulation B in fasted state will be analyzed.	Up to 10 days
Secondary	Dose proportionality in BAY1817080 PK after a single oral dose of Formulation B across three doses in fasted state evaluated by AUC/D	To investigate dose-proportionality, AUC divided by dose (AUC/D) derived from the 3 oral doses of Formulation B in fasted state will be analyzed. AUC(0-tlast)/D will be used if AUC/D cannot be calculated reliably in all subjects.	Up to 10 days
Secondary	Frequency and severity of treatment emergent adverse events (TEAEs)		Up to 42 days