EndometriosisPhase 1NCT02434640
Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
A Phase 1 study testing BAY1128688 in people with Endometriosis, run by Bayer at 3 sites in Germany.
Trial summary
The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women. Read more about this study
- Who is it for?
- Ages 18 to 68 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- BAY1128688
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2015to Apr 2016
- 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 68 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PART A
- Postmenopausal state, revealed by
- Medical history. One of the following:
- Natural menopause at least 12 months prior to first study drug administration,
- Surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration) or
- Hysterectomy AND
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- Follicle-stimulating hormone (FSH) > 40 IU/L
- Age 45 to 68 years
- PART B
- Healthy female subjects
- Sterilized by tubal-ligation
- Pre-treatment menstrual cycle assessed as ovulatory
- Completion of more than 3 menstrual cycles after delivery, abortion or lactation
- Age 18 to 48 years
Who cannot join
- Body mass index (kg/m2) greater or equal 32 (or less or equal 18)
- Smoking: PART A: non-smoking; PART B: less than 10 cigarettes per day
- Use of medicines including but not restricted to contraceptives and NSAIDs (details regarding previous use of medicines provided by the study center)
- Ability and willingness to adhere to restrictions regarding diet (PART A and B) and to eat standardised meals (PART A only)
- Significant diseases of the heart, gastrointestinal tract and/or liver and/or kidney and/or reproductive organs (present or in the past; details will be provided by the study center)
- Recent infectious diseases (details will be provided by the study center)
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- Migraine or depression
- Thyroid disease which requires treatment
- Metabolic disorders, for example diabetes mellitus or hypertriglyceridemia
- Drug or alcohol abuse; regular consumption of more than 800 ml of beer per day (or other drinks resembling 40 g of alcohol)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Study site
Berlin, State of Berlin, 13353
Study site
Berlin, State of Berlin, 14050
Study site
Neu-Ulm, Bavaria, 89231
About this study
The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.
- Conditions
- Endometriosis
- Being tested
- BAY1128688, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1128688Drug
Part A: Single dose and multiple dose for 14 days (postmenopausal women)
PlaceboDrug
Part A: Single dose and multiple dose for 14 days (postmenopausal women)
BAY1128688Drug
Part B: Multiple dose for 28 days (premenopausal women)
| Study group | Role | What they receive |
|---|---|---|
| BAY1128688 [Dose1] | Experimental | BAY1128688 dose level 1 Receives: Drug: BAY1128688 |
| BAY1128688 [Dose2] | Experimental | BAY1128688 dose level 2 Receives: Drug: BAY1128688 |
| BAY1128688 [Dose3] | Experimental | BAY1128688 dose level 3 Receives: Drug: BAY1128688 |
| BAY1128688 [Dose4] | Experimental | BAY1128688 dose level 4 Receives: Drug: BAY1128688 |
| Placebo | Placebo comparator | Placebo to match arm 1,2, 3 and 4 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
Measured: Up to 2 months
Cmax,md (maximum concentration) of BAY1128688 after multiple dose
Measured: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Cav,md (average steady state concentration) of BAY1128688 after multiple dose
Measured: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionApr 2016
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 EndometriosisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 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
- NCT02434640
- Sponsor's protocol ID
- 16742
- Other IDs
- 2014-005298-36, 2014
- Status last verified
- May 2016
- First submitted
- 30 Apr 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gashaw I, Reif S, Wiesinger H, Kaiser A, Zollmann FS, Scheerans C, Grevel J, Piraino P, Seidel H, Peters M, Rottmann A, Rohde B, Arlt W, Hilpert J. Novel aldo-keto reductase 1C3 inhibitor affects androgen metabolism but not ovarian function in healthy women: a phase 1 study. Eur J Endocrinol. 2023 Jul 10;188(7):578-591. doi: 10.1093/ejendo/lvad063.
PubMed 37306288
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
- ClinicalTrials.gov ID
- NCT02434640
- Acronym / sponsor ID
- 16742
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 May 2015 (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.
The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BAY1128688 [Dose1] | Experimental | Drug: BAY1128688BAY1128688 dose level 1 |
| BAY1128688 [Dose2] | Experimental | Drug: BAY1128688BAY1128688 dose level 2 |
| BAY1128688 [Dose3] | Experimental | Drug: BAY1128688BAY1128688 dose level 3 |
| BAY1128688 [Dose4] | Experimental | Drug: BAY1128688BAY1128688 dose level 4 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match arm 1,2, 3 and 4 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- PART A
- Postmenopausal state, revealed by
- Age 45 to 68 years
- PART B
- Healthy female subjects
Key exclusion criteria (10 listed)
- Body mass index (kg/m2) greater or equal 32 (or less or equal 18)
- Smoking: PART A: non-smoking; PART B: less than 10 cigarettes per day
- Use of medicines including but not restricted to contraceptives and NSAIDs (details regarding previous use of medicines provided by the study center)
- Ability and willingness to adhere to restrictions regarding diet (PART A and B) and to eat standardised meals (PART A only)
- Significant diseases of the heart, gastrointestinal tract and/or liver and/or kidney and/or reproductive organs (present or in the past; details will be provided by the study center)
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 |
|---|---|---|
| BAY1128688Part A: Single dose and multiple dose for 14 days (postmenopausal women) | Drug | BAY1128688 [Dose1], BAY1128688 [Dose2], BAY1128688 [Dose3], BAY1128688 [Dose4] |
| PlaceboPart A: Single dose and multiple dose for 14 days (postmenopausal women) | Drug | Placebo |
| BAY1128688Part B: Multiple dose for 28 days (premenopausal women) | Drug | BAY1128688 [Dose2], BAY1128688 [Dose3] |
Primary outcome
Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
Time frame: Up to 2 months
Cmax,md (maximum concentration) of BAY1128688 after multiple dose
Time frame: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Cav,md (average steady state concentration) of BAY1128688 after multiple dose
Time frame: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
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 19 May 2016.
- Derived from this study: PubMed 37306288Gashaw I, Reif S, Wiesinger H, Kaiser A, Zollmann FS, Scheerans C, Grevel J, Piraino P, Seidel H, Peters M, Rottmann A, Rohde B, Arlt W, Hilpert J. Novel aldo-keto reductase 1C3 inhibitor affects androgen metabolism but not ovarian function in healthy women: a phase 1 study. Eur J Endocrinol. 2023 Jul 10;188(7):578-591. doi: 10.1093/ejendo/lvad063.
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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
3 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 BAY1128688 in people with Endometriosis, run by Bayer at 3 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 14 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: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 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?
Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading (time frame: Up to 2 months). The study lists 3 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 NCT02434640, 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 May 2016.