- ICH GCP
- US Clinical Trials Registry
- 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
August 16, 2019 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9728 NZ
- Prahealthsciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
Formulation B
Formulation A
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
|
Formulation B
Formulation A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute oral bioavailability (F) of BAY1817080
Time Frame: Up to 10 days
|
Up to 10 days
|
Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets
Time Frame: Up to 10 days
|
Up to 10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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
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.
|
Up to 10 days
|
Frequency and severity of treatment emergent adverse events (TEAEs)
Time Frame: Up to 42 days
|
Up to 42 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2018
Primary Completion (Actual)
June 21, 2019
Study Completion (Actual)
August 12, 2019
Study Registration Dates
First Submitted
December 4, 2018
First Submitted That Met QC Criteria
December 10, 2018
First Posted (Actual)
December 12, 2018
Study Record Updates
Last Update Posted (Actual)
August 19, 2019
Last Update Submitted That Met QC Criteria
August 16, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19519
- 2018-001814-13 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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