Polycystic Ovary SyndromePhase 1NCT03119077
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
A Phase 1 study testing BAY1161116 and Itraconazole in people with Polycystic Ovary Syndrome, run by Bayer at 1 site in Germany.
Trial summary
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- BAY1161116 and Itraconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2017to 31 Jan 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female postmenopausal subjects
- Age: 45 to 65 years (inclusive)
- Body mass index (BMI) : ≥18 and ≤30 kg/m²
- Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
Who cannot join
- Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
- Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
- Any severe disease within the last 4 weeks prior to the first study drug administration
- History of orthostatic hypotension, fainting spells, blackouts
- Any malignant tumor and history thereof
- Any other medical condition which, at the discretion of the investigator, would make study participation unadvisable
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- Any clinically relevant finding at the physical- and gynecological examinations
- Allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the IMP or reference/interaction product
- Regular alcohol consumption equivalent to >20 g alcohol per day
- Urine screen positive for any drug or cotinine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Escalating Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered BAY1161116 in Healthy Postmenopausal Women Including Food-effect and Drug-drug-interaction With Itraconazole
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- BAY1161116, Placebo, Itraconazole
- Keywords
- PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1161116Drug
Escalating doses of BAY1161116; single dose administration; redosing of BAY1161116 at dose group 1 together with itraconazole; redosing of BAY1161116 at dose group 2 as liquid service formulation, redosing of BAY1161116 at dose group 3 together with food
PlaceboDrug
Escalating doses of respective placebos; single dose administration; redosing of placebo at dose group 1 together with itraconazole; redosing of placebo at dose group 2 as liquid service formulation, redosing of placebo at dose group 3 together with food
ItraconazoleDrug
Redosing of BAY1161116/placebo at dose group 1 together with itraconazole
| Study group | Role | What they receive |
|---|---|---|
| BAY1161116 | Experimental | Dose steps 1 to 6 of BAY1161116 (increasing dose levels) Receives: Drug: BAY1161116; Drug: Itraconazole |
| Placebo | Placebo comparator | Placebo Dose 1 to 6 of BAY 1161116 Receives: Drug: Placebo; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs
TEAEs: treatment-emergent adverse events
Measured: 5 weeks
Severity of TEAEs
TEAEs: treatment-emergent adverse events
Measured: 5 weeks
AUC of BAY1161116
AUC: Area under the concentration vs. time curve from zero to infinity
Measured: 5 weeks
Cmax of BAY1161116
Cmax: maximum observed drug concentration
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start27 Apr 2017
- Primary completion8 Sep 2017
- Study completion31 Jan 2018
Why it stopped: Study early terminated due to lower drug exposure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119077
- Sponsor's protocol ID
- 18752
- Other IDs
- 2016-003520-23, 2016
- Status last verified
- May 2018
- First submitted
- 13 Apr 2017
- Last updated
- 17 May 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 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Escalating Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered BAY1161116 in Healthy Postmenopausal Women Including Food-effect and Drug-drug-interaction With Itraconazole
- ClinicalTrials.gov ID
- NCT03119077
- Acronym / sponsor ID
- 18752
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study early terminated due to lower drug exposure
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY1161116 | Experimental | Drug: BAY1161116, Drug: ItraconazoleDose steps 1 to 6 of BAY1161116 (increasing dose levels) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: ItraconazolePlacebo Dose 1 to 6 of BAY 1161116 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy female postmenopausal subjects
- Age: 45 to 65 years (inclusive)
- Body mass index (BMI) : ≥18 and ≤30 kg/m²
- Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
Key exclusion criteria (10 listed)
- Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
- Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
- Any severe disease within the last 4 weeks prior to the first study drug administration
- History of orthostatic hypotension, fainting spells, blackouts
- Any malignant tumor and history thereof
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 |
|---|---|---|
| BAY1161116Escalating doses of BAY1161116; single dose administration; redosing of BAY1161116 at dose group 1 together with itraconazole; redosing of BAY1161116 at dose group 2 as liquid service formulation, redosing of BAY1161116 at dose group 3 together with food | Drug | BAY1161116 |
| PlaceboEscalating doses of respective placebos; single dose administration; redosing of placebo at dose group 1 together with itraconazole; redosing of placebo at dose group 2 as liquid service formulation, redosing of placebo at dose group 3 together with food | Drug | Placebo |
| ItraconazoleRedosing of BAY1161116/placebo at dose group 1 together with itraconazole | Drug | BAY1161116, Placebo |
Primary outcome
Incidence of TEAEs
Time frame: 5 weeks
TEAEs: treatment-emergent adverse events
Severity of TEAEs
Time frame: 5 weeks
TEAEs: treatment-emergent adverse events
AUC of BAY1161116
Time frame: 5 weeks
AUC: Area under the concentration vs. time curve from zero to infinity
Cmax of BAY1161116
Time frame: 5 weeks
Cmax: maximum observed drug concentration
Results and safety
The study was stopped early (reason given: Study early terminated due to lower drug exposure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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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
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 BAY1161116 and Itraconazole in people with Polycystic Ovary Syndrome, 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 10 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: stopped early, as of the sponsor's last update on 17 May 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study early terminated due to lower drug exposure). Results are not available in the source record.
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?
Incidence of TEAEs (time frame: 5 weeks). The study lists 4 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 17 May 2018.