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

• Status: Terminated
• Trial end date: 2018-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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