Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116

Bayer

Status and phase: Terminated; Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: BAY1161116; Drug: Itraconazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03119077

2016-003520-23 (EudraCT Number)

18752

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

BAY1161116

Experimental group

Description:

Dose steps 1 to 6 of BAY1161116 (increasing dose levels)

Treatment:

Drug: Itraconazole

Drug: BAY1161116

Placebo

Placebo Comparator group

Description:

Placebo Dose 1 to 6 of BAY 1161116

Treatment:

Drug: Itraconazole

Drug: Placebo