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

• ClinicalTrials.gov Identifier: NCT03119077
• Recruitment Status: Terminated
• First Posted: April 18, 2017
• Last Update Posted: May 17, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome	Drug: BAY1161116; Drug: Placebo; Drug: Itraconazole	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: April 27, 2017
• Actual Primary Completion Date: September 8, 2017
• Actual Study Completion Date: January 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: BAY1161116; Dose steps 1 to 6 of BAY1161116 (increasing dose levels)	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; Drug: Itraconazole; Redosing of BAY1161116/placebo at dose group 1 together with itraconazole
Placebo Comparator: Placebo; Placebo Dose 1 to 6 of BAY 1161116	Drug: 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; Drug: Itraconazole; Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Outcome Measures

Primary Outcome Measures :

1. Incidence of TEAEs [ Time Frame: 5 weeks ]
   TEAEs: treatment-emergent adverse events
2. Severity of TEAEs [ Time Frame: 5 weeks ]
   TEAEs: treatment-emergent adverse events
3. AUC of BAY1161116 [ Time Frame: 5 weeks ]
   AUC: Area under the concentration vs. time curve from zero to infinity
4. Cmax of BAY1161116 [ Time Frame: 5 weeks ]
   Cmax: maximum observed drug concentration

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Germany

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03119077
• Other Study ID Numbers: 18752; 2016-003520-23 ( EudraCT Number )
• First Posted: April 18, 2017
• Last Update Posted: May 17, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

PCOS

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Itraconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inhibitors