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Clinical PharmacologyPhase 1NCT04364464

Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

A Phase 1 study testing Riociguat (Adempas, BAY 63-2521) in people with Clinical Pharmacology, run by Bayer at 1 site in Germany.

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

BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn more about the safety of BAY 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the… Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Clinical Pharmacology
What is being tested?
Riociguat (Adempas, BAY 63-2521)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
19 Feb 2010to 20 Sep 2011
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 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female white subjects with 18 to ≤79 years of age, BMI between 18 and 34 kg/m^2
  • Women without childbearing potential or with childbearing potential but only if the pregnancy test is negative and are under highly effective contraception
  • Stable renal disease, ie. a serum creatinine value determined at least 3 - 6 months before the pre-study visit was not allowed to vary by more than 20% from the serum creatinine value determined at the pre-study visit
  • Mean age and body weight not allowed to vary by more than +/- 10 years and +/- 10 kg from the subjects with renal impairment, respectively

Who cannot join

  • Febrile illness within 1 week before the start of the study
  • Hypersensitivity to riociguat and / or to inactive constituents
  • Smoking
  • Resting heart rate in the awake subject below 45 BPM or above 90 BPM
  • Acute renal failure or nephritis
  • Any organ transplant
Show all 17Show fewer
  • Diastolic blood pressure (DBP) >100 mmHg and / or systolic blood pressure (SBP) >180 mmHg
  • Hemoglobin <8 g/dL, Proteinuria >8 g/24 hours, Serum albumin <30 g/L, Platelet count <100 x 109/L
  • History of bleeding within the past 3 months
  • Diabetes mellitus with a fasting blood glucose >220 mg/dL or HbA1c >10%
  • Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications
  • Concomitant use of phosphodiesterase-5 inhibitors, endothelin receptor antagonists (ERAs, eg bosentan), intravenous or inhalative prostacyclins, or nitrates
  • Concomitant use of potent CYP3A4 inhibitors
  • Conspicuous findings in medical history or pre-study examination
  • History of relevant diseases of vital organs, central nervous system, or other organs
  • SBP below 100 mmHg or above 145 mmHg and / or DBP above 95 mmHg
  • Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Study site

    Kiel, Schleswig-Holstein, 24105

Other trials in Germany

About this study

Official title: Investigation of Pharmacokinetics, Safety, and Tolerability of BAY 63-2521 in Male and Female Subjects With Renal Impairment and in Age- and Weight- Matched Healthy Subjects Following a Single Oral Dose of 1 mg BAY 63-2521 in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification

BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn more about the safety of BAY 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight

Being tested
Riociguat (Adempas, BAY 63-2521)

What participants receive

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

  • Riociguat (Adempas, BAY 63-2521)Drug

    0.5 mg riociguat as an immediate-release (IR) tablet

Study groups in NCT04364464
Study groupRoleWhat they receive
Riociguat, healthy participantsExperimentalParticipants with creatinine clearance (CLCR) >80 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
Receives: Drug: Riociguat (Adempas, BAY 63-2521)
Riociguat, mild renal impairmentExperimentalParticipants with CLCR 50-80 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
Receives: Drug: Riociguat (Adempas, BAY 63-2521)
Riociguat, moderate renal impairmentExperimentalParticipants with CLCR 30-<50 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
Receives: Drug: Riociguat (Adempas, BAY 63-2521)
Riociguat, severe renal impairmentExperimentalParticipants with CLCR <30 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
Receives: Drug: Riociguat (Adempas, BAY 63-2521)

What is being measured

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

  1. AUC

    Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552)

    Measured: Pre-dose up to 72 hours post-dose

  2. Cmax

    Maximum total (bound and unbound) drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  3. t½

    Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  4. fu

    Fraction unbound for BAY 63-2521 and its metabolite M1

    Measured: From 2 hours post-dose up to 24 hours post-dose

  5. AUCu

    AUC for unbound drug for BAY 63-2521 and its metabolite M1

    Measured: From 2 hours post-dose up to 24 hours post-dose

  6. Cmax,u

    Cmax for unbound drug for BAY 63-2521 and its metabolite M1

    Measured: From 2 hours post-dose up to 24 hours post-dose

Secondary outcomes (15)

  1. AUC/D

    AUC divided by dose for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  2. AUCnorm

    AUC divided by dose per kg body weight for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  3. AUCu,norm

    AUCnorm for unbound drug for BAY 63-2521 and its metabolite M1

    Measured: From 2 hours post-dose up to 24 hours post-dose

  4. AUC(0-tlast)

    AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  5. Cmax/D

    Cmax divided by dose for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  6. Cmax,norm

    Cmax divided by dose per kg body weight for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  7. Cmax,u,norm

    Cmax,norm for unbound drug for BAY 63-2521 and its metabolite M1

    Measured: From 2 hours post-dose up to 24 hours post-dose

  8. tmax

    Time to reach Cmax (in case of two identical Cmax values, the first tmax was used) for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  9. MRT

    Mean residence time for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  10. CL/F

    Total body clearance of drug calculated after extravascular administration (eg apparent oral clearance) for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  11. CLu/F

    CL/F for unbound drug for BAY 63-2521 and its metabolite M1

    Measured: From 2 hours post-dose up to 24 hours post-dose

  12. Vz/F

    Apparent volume of distribution during terminal phase after extravascular administration for BAY 63-2521 and its metabolite M1

    Measured: Pre-dose up to 72 hours post-dose

  13. AE,ur

    Amount of (total) drug excreted in urine for BAY 63-2521 and its metabolite M1

    Measured: From 24 hours prior to drug administration up to 72 hours post-dose

  14. CLR

    Renal body clearance of drug for BAY 63-2521 and its metabolite M1

    Measured: From 24 hours prior to drug administration up to 72 hours post-dose

  15. Number of participants with adverse events

    Measured: Approximately 5 weeks

Timeline

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

  1. First posted28 Apr 2020
  2. Study start19 Feb 2010
  3. Primary completion17 Mar 2011
  4. Study completion20 Sep 2011

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364464
Sponsor's protocol ID
15000
Other IDs
2009-017685-23, 2009
Status last verified
Apr 2020
First submitted
23 Apr 2020
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Riociguat (Adempas, BAY 63-2521) in people with Clinical Pharmacology, run by Bayer at 1 site in Germany.

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 17 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 28 Apr 2020. 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 Germany. 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?

AUC (time frame: Pre-dose up to 72 hours post-dose). The study lists 6 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 NCT04364464.

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 28 Apr 2020.

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