check_circleStudy Completed

Biological Availability

Bayer Identifier:

19519

ClinicalTrials.gov Identifier:

NCT03773068

EudraCT Number:

2018-001814-13

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • 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

Trial summary

Enrollment Goal
30
Trial Dates
December 2018 - August 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PRAHealthSciencesGRONINGEN, 9728 NZ, Netherlands

Primary Outcome

  • Absolute oral bioavailability (F) of BAY1817080
    date_rangeTime Frame:
    Up to 10 days
  • Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets
    date_rangeTime Frame:
    Up to 10 days

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 10 days
  • 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.
    date_rangeTime Frame:
    Up to 10 days
  • 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.
    date_rangeTime Frame:
    Up to 10 days
  • 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.
    date_rangeTime Frame:
    Up to 10 days
  • Frequency and severity of treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 42 days

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3