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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

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ClinicalTrials.gov Identifier: NCT03773068
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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Study Type : Interventional  (Clinical Trial)
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 : December 13, 2018
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : August 12, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Absolute oral bioavailability (F) of BAY1817080 [ Time Frame: Up to 10 days ]
  2. Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 42 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773068


Locations
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Netherlands
PRAHealthSciences
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03773068    
Other Study ID Numbers: 19519
2018-001814-13 ( EudraCT Number )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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