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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03119077

Enrollment

Registered

2017-04-18

Start date

2017-04-27

Completion date

2018-01-31

Last updated

2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Brief 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.

Interventions

DRUGBAY1161116

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

DRUGPlacebo

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

DRUGItraconazole

Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of TEAEs	5 weeks	TEAEs: treatment-emergent adverse events
Severity of TEAEs	5 weeks	TEAEs: treatment-emergent adverse events
AUC of BAY1161116	5 weeks	AUC: Area under the concentration vs. time curve from zero to infinity
Cmax of BAY1161116	5 weeks	Cmax: maximum observed drug concentration

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026