Clinical trial · Interventional
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study early terminated due to lower drug exposure
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1161116 | Drug | — | UNRESOLVED |
| Itraconazole | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BAY1161116
- description
- Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
- interventionNames
- Drug: BAY1161116
- Drug: Itraconazole
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo Dose 1 to 6 of BAY 1161116
- interventionNames
- Drug: Placebo
- Drug: Itraconazole
Primary outcomes (4)
- measure
- Incidence of TEAEs
- timeFrame
- 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available