AzTrials
AzTrials

Biological AvailabilityPhase 1NCT03773068

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

A Phase 1 study testing BAY1817080 - Formulation A, BAY1817080 - Formulation B and [13C715N]-BAY 181708 stable isotope label (SIL) in people with Biological Availability, run by Bayer at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Biological Availability
What is being tested?
BAY1817080 - Formulation A, BAY1817080 - Formulation B and [13C715N]-BAY 181708 stable isotope label (SIL)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
13 Dec 2018to 12 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRAHealthSciences

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

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

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.

Being tested
BAY1817080 - Formulation A, BAY1817080 - Formulation B, [13C715N]-BAY 181708 stable isotope label (SIL)
Keywords
Endometriosis, Refractory chronic cough
Medical subject headings
Endometriosis, Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1817080 - Formulation ADrug

    Formulation A

  • BAY1817080 - Formulation BDrug

    Formulation B

  • [13C715N]-BAY 181708 stable isotope label (SIL)Drug

    0.1 mg [13C715N]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B

Study groups in NCT03773068
Study groupRoleWhat they receive
Group 1 - BAY1817080 Dose 1ExperimentalParticipants will receive one single oral dose of BAY1817080 - Formulation B at dose 1 under fasted condition
Receives: Drug: BAY1817080 - Formulation B
Group 2 - BAY1817080 Dose 2ExperimentalParticipants 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
Receives: Drug: BAY1817080 - Formulation A; Drug: BAY1817080 - Formulation B; Drug: [13C715N]-BAY 181708 stable isotope label (SIL)
Group 3 - BAY1817080 Dose 3ExperimentalParticipants 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
Receives: Drug: BAY1817080 - Formulation A; Drug: BAY1817080 - Formulation B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute oral bioavailability (F) of BAY1817080

    Measured: Up to 10 days

  2. Relative bioavailability (frel) of Formulation A versus Formulation B given under different diets

    Measured: Up to 10 days

Secondary outcomes (5)

  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

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

    Measured: Up to 10 days

  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

    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.

    Measured: Up to 10 days

  3. 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.

    Measured: Up to 10 days

  4. 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.

    Measured: Up to 10 days

  5. Frequency and severity of treatment emergent adverse events (TEAEs)

    Measured: Up to 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2018
  2. Study start13 Dec 2018
  3. Primary completion21 Jun 2019
  4. Study completion12 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773068
Sponsor's protocol ID
19519
Other IDs
2018-001814-13, 2018
Status last verified
Aug 2019
First submitted
4 Dec 2018
Last updated
19 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Francke K, Chattopadhyay N, Klein S, Rottmann A, Krickau D, van de Wetering J, Friedrich C. Preclinical and Clinical Pharmacokinetics and Bioavailability in Healthy Volunteers of a Novel Formulation of the Selective P2X3 Receptor Antagonist Eliapixant. Eur J Drug Metab Pharmacokinet. 2023 Jan;48(1):75-87. doi: 10.1007/s13318-022-00805-5. Epub 2022 Dec 5.

    PubMed 36469250

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1817080 - Formulation A, BAY1817080 - Formulation B and [13C715N]-BAY 181708 stable isotope label (SIL) in people with Biological Availability, run by Bayer at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute oral bioavailability (F) of BAY1817080 (time frame: Up to 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03773068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.

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