Biological AvailabilityPhase 1NCT03048110
Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction
A Phase 1 study testing BAY1841788 (ODM-201), Itraconazole and Rifampicin in people with Biological Availability, run by Bayer at 1 site in Germany.
Trial summary
Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201) Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- BAY1841788 (ODM-201), Itraconazole and Rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2017to 19 Jul 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.
- Gender: Male.
- Age: 45 to 65 years (inclusive) at the screening visit.
- Race: White.
- Body mass index (BMI): ≥18.0 and ≤30 kg/m^2.
- Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with ODM-201. In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception.
- Results of alcohol tests are negative at screening and on Study Day -1.
Who cannot join
- Medical and surgical history
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Febrile illness within 1 week before the first study drug administration.
- A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT Syndrome) or other arrhythmias.
- Known severe allergies, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated, asymptomatic seasonal allergies like non-severe hay fever during the time of study conduct).
Show all 11Show fewer
- Known history of hypersensitivity (or known allergic reaction) to itraconazole, rifampicin or ODM-201.
- Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.
- Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.
- Subjects with porphyria.
- Subjects with diagnosed malignancy within the past 5 years except for cured skin basal carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of a Probe CYP3A4 Inhibitor and Inducer on the Pharmacokinetics of BAY1841788 (ODM 201) in Healthy Male Volunteers
Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)
- Conditions
- Biological Availability
- Being tested
- BAY1841788 (ODM-201), Itraconazole, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1841788 (ODM-201)Drug
In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.
ItraconazoleDrug
200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7.
RifampicinDrug
600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10.
| Study group | Role | What they receive |
|---|---|---|
| ODM-201 | Experimental | All subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period Receives: Drug: BAY1841788 (ODM-201); Drug: Itraconazole; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured.
Measured: Pre dose to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration after single dose administration in plasma were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours (AUC[0-72h]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured.
Measured: Pre dose up to 72 hours post dose of darolutamide
Secondary outcomes (1)
Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment-emergent (TE). AEs that occurred on study drug administration were termed as study drug related adverse events.
Measured: From start of study drug administration up to 30 days after last dose of 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 Feb 2017 (estimated)
- Study start15 Feb 2017
- Primary completion4 May 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT03048110
- Sponsor's protocol ID
- 17726
- Other IDs
- 2016-004469-20, 2016
- Status last verified
- Jul 2018
- First submitted
- 8 Feb 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of a Probe CYP3A4 Inhibitor and Inducer on the Pharmacokinetics of BAY1841788 (ODM 201) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03048110
- Acronym / sponsor ID
- 17726
- Conditions
- Biological Availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 9 Feb 2017 (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 effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODM-201 | Experimental | Drug: BAY1841788 (ODM-201), Drug: Itraconazole, Drug: RifampicinAll subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.
- Gender: Male.
- Age: 45 to 65 years (inclusive) at the screening visit.
- Race: White.
- Body mass index (BMI): ≥18.0 and ≤30 kg/m^2.
Key exclusion criteria (11 listed)
- Medical and surgical history
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Febrile illness within 1 week before the first study drug administration.
- A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT Syndrome) or other arrhythmias.
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 |
|---|---|---|
| BAY1841788 (ODM-201)In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8. | Drug | ODM-201 |
| Itraconazole200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7. | Drug | ODM-201 |
| Rifampicin600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10. | Drug | ODM-201 |
Primary outcome
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured.
Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration after single dose administration in plasma were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured.
Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours (AUC[0-72h]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured.
Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured.
1 secondary outcome
Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to 30 days after last dose of 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 30 Jul 2018.
Related trials for Biological Availability
Not yet recruitingPhase 1
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses
Obesity, Overweight
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
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
1 site 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 (ODM-201), Itraconazole and Rifampicin in people with Biological Availability, 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 7 inclusion and 11 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 30 Jul 2018. 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?
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide (time frame: Pre dose to 72 hours post dose of darolutamide). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2018.