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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03773068
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 8
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biological Availability	Drug: BAY1817080 - Formulation A; Drug: BAY1817080 - Formulation B; Drug: [13C715N]-BAY 181708 stable isotope label (SIL)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Dec 13, 2018
• Actual Primary Completion Date: Jun 21, 2019
• Actual Study Completion Date: Aug 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 - BAY1817080 Dose 1 Participants will receive one single oral dose of BAY1817080 - Formulation B at dose 1 under fasted condition	Drug: BAY1817080 - Formulation B; Formulation B
Experimental: 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	Drug: BAY1817080 - Formulation A; Formulation A; Drug: BAY1817080 - Formulation B; Formulation B; 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
Experimental: 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	Drug: BAY1817080 - Formulation A; Formulation A; Drug: BAY1817080 - Formulation B; Formulation B

Outcome Measures

Primary Outcome Measures

1. Absolute oral bioavailability (F) of BAY1817080 [Up to 10 days]

2. Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets [Up to 10 days]

Secondary Outcome Measures

1. 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 [Up to 10 days]

   Maximum observed drug concentration in plasma after single dose administration (Cmax) of BAY1817080 will be analyzed assuming log-normally distributed data.

2. 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 [Up to 10 days]

   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.

3. Dose proportionality in BAY1817080 PK after a single oral dose of Formulation B across three doses in fasted state evaluated by Cmax/D [Up to 10 days]

   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.

4. Dose proportionality in BAY1817080 PK after a single oral dose of Formulation B across three doses in fasted state evaluated by AUC/D [Up to 10 days]

   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.

5. Frequency and severity of treatment emergent adverse events (TEAEs) [Up to 42 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRAHealthSciences	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03773068
• Other Study ID Numbers: 19519; 2018-001814-13
• First Posted: Dec 12, 2018
• Last Update Posted: Aug 19, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bayer: Endometriosis; Refractory chronic cough

Study Results

No Results Posted as of Aug 19, 2019