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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03119077
• Other study ID #: 18752
• Secondary ID: 2016-003520-23
• Status: Terminated
• Phase: Phase 1
• Start date: April 27, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: May 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 31, 2018
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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

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