Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
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ClinicalTrials.gov Identifier: NCT03119077 |
Recruitment Status :
Terminated
(Study early terminated due to lower drug exposure)
First Posted : April 18, 2017
Last Update Posted : May 17, 2018
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Drug: BAY1161116 Drug: Placebo Drug: Itraconazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
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 |
Actual Study Start Date : | April 27, 2017 |
Actual Primary Completion Date : | September 8, 2017 |
Actual Study Completion Date : | January 31, 2018 |

Arm | Intervention/treatment |
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Experimental: BAY1161116
Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
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Drug: BAY1161116
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 Drug: Itraconazole Redosing of BAY1161116/placebo at dose group 1 together with itraconazole |
Placebo Comparator: Placebo
Placebo Dose 1 to 6 of BAY 1161116
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Drug: Placebo
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 Drug: Itraconazole Redosing of BAY1161116/placebo at dose group 1 together with itraconazole |
- 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

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Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119077
Germany | |
CRS Clinical Research Services Berlin GmbH | |
Berlin, Germany, 13353 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT03119077 |
Other Study ID Numbers: |
18752 2016-003520-23 ( EudraCT Number ) |
First Posted: | April 18, 2017 Key Record Dates |
Last Update Posted: | May 17, 2018 |
Last Verified: | May 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
PCOS |
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Itraconazole Antifungal Agents |
Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors |