PharmacokineticsPhase 1NCT02894385
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
A Phase 1 study testing BAY1841788 in people with Pharmacokinetics and Hepatic Insufficiency, run by Bayer at 2 sites in Germany.
Trial summary
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201). Read more about this study
- Who is it for?
- Ages 45 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency
- What is being tested?
- BAY1841788
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Sep 2016to 15 Dec 2017
- 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 45 to 79 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects
- -- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg/m2 (both inclusive).
- Patients with moderate hepatic impairment (Part 1)
- -- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).
- Patients with severe renal impairment (Part 1)
- -- Patients with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m2, who are not on dialysis and are not expected to start dialysis in the next 3 months (Stage 4).
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- Healthy subjects
- -- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and with estimated glomerular filtration rate >90 mL/min (according to Modified Diet of Renal Disease equation).
- Patients with moderate renal impairment (Part 2)
- -- Patients with moderate renal impairment with an estimated glomerular filtration rate 30-59 mL/min/1.73 m2 (Stage 3).
- Patients with mild renal impairment (Part 2)
- -- Patients with mild renal impairment with an estimated glomerular filtration rate (eGFR) 60-79 mL/min/1.73 m2 (Stage 2).
- Patients with mild hepatic impairment (Part 2)
- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan.
- Patients with mild hepatic impairment (defined as Child Pugh class A).
Who cannot join
- Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV.
- Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration.
- Strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- Known BCRP (breast cancer resistant protein) and OATP (organic anion-transporting polypeptide) substrates not specifically mentioned in the protocol within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- Smoking more than 20 cigarettes daily.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Lübeck, 23538
About this study
Official title: A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
Read the detailed description
The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.
- Conditions
- Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency
- Being tested
- BAY1841788
- Medical subject headings
- Hepatic Insufficiency, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1841788Drug
600 mg single dose, administered as 2 x 300 mg tablets on Day 00.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Subjects with severe renal impairment | Experimental | Subjects with severe renal impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). Receives: Drug: BAY1841788 |
| Part 1 - Subjects with moderate hepatic impairment | Experimental | Subjects with moderate hepatic impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). Receives: Drug: BAY1841788 |
| Part 1 - Healthy subjects | Experimental | Healthy subjects received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). Receives: Drug: BAY1841788 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
Measured: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide in plasma
Measured: Pre-dose up to 48 h post dose
Secondary outcomes (7)
Area under the concentration-time curve of darolutamide's diastereomer ((S,R)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Measured: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma
Measured: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's diastereomer ((S,S)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Measured: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma
Measured: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's major metabolite (keto-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Measured: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma
Measured: Pre-dose up to 48 h post dose
Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)
Measured: From first application of study medication up to 30 days after end of treatment with study medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start13 Sep 2016
- Primary completion10 Apr 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894385
- Sponsor's protocol ID
- 17721
- Other IDs
- 2016-001069-10, 2016
- Status last verified
- Jan 2019
- First submitted
- 29 Aug 2016
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.
PubMed 34866168
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function
- ClinicalTrials.gov ID
- NCT02894385
- Acronym / sponsor ID
- 17721
- Conditions
- Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
Detailed description
The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Subjects with severe renal impairment | Experimental | Drug: BAY1841788Subjects with severe renal impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). |
| Part 1 - Subjects with moderate hepatic impairment | Experimental | Drug: BAY1841788Subjects with moderate hepatic impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). |
| Part 1 - Healthy subjects | Experimental | Drug: BAY1841788Healthy subjects received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All subjects
- -- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg/m2 (both inclusive).
- Patients with moderate hepatic impairment (Part 1)
- -- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).
- Patients with severe renal impairment (Part 1)
Key exclusion criteria (5 listed)
- Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV.
- Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration.
- Strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- Known BCRP (breast cancer resistant protein) and OATP (organic anion-transporting polypeptide) substrates not specifically mentioned in the protocol within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- Smoking more than 20 cigarettes daily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY1841788600 mg single dose, administered as 2 x 300 mg tablets on Day 00. | Drug | Part 1 - Healthy subjects, Part 1 - Subjects with moderate hepatic impairment, Part 1 - Subjects with severe renal impairment |
Primary outcome
Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide in plasma
Time frame: Pre-dose up to 48 h post dose
7 secondary outcomes
Area under the concentration-time curve of darolutamide's diastereomer ((S,R)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma
Time frame: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's diastereomer ((S,S)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma
Time frame: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's major metabolite (keto-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma
Time frame: Pre-dose up to 48 h post dose
Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)
Time frame: From first application of study medication up to 30 days after end of treatment with study medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Derived from this study: PubMed 34866168Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1841788 in people with Pharmacokinetics and Hepatic Insufficiency, run by Bayer at 2 sites 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 15 inclusion and 5 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma (time frame: Pre-dose up to 48 h post dose). 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 NCT02894385, 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 7 Jan 2019.