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

Primary Purpose

Polycystic Ovary Syndrome

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BAY1161116

Placebo

Itraconazole

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring PCOS

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

CRS Clinical Research Services Berlin GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BAY1161116

Placebo

Arm Description

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

Placebo Dose 1 to 6 of BAY 1161116

Outcomes

Primary Outcome Measures

Incidence of TEAEs

TEAEs: treatment-emergent adverse events

Severity of TEAEs

TEAEs: treatment-emergent adverse events

AUC of BAY1161116

AUC: Area under the concentration vs. time curve from zero to infinity

Cmax of BAY1161116

Cmax: maximum observed drug concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT03119077

First Posted

April 13, 2017

Last Updated

May 15, 2018

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03119077

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Study early terminated due to lower drug exposure

Study Start Date

April 27, 2017 (Actual)

Primary Completion Date

September 8, 2017 (Actual)

Study Completion Date

January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

PCOS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY1161116

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Dose 1 to 6 of BAY 1161116

Intervention Type

Drug

Intervention Name(s)

BAY1161116

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Itraconazole

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of TEAEs

Description

TEAEs: treatment-emergent adverse events

Time Frame

5 weeks

Title

Severity of TEAEs

Description

TEAEs: treatment-emergent adverse events

Time Frame

5 weeks

Title

AUC of BAY1161116

Description

AUC: Area under the concentration vs. time curve from zero to infinity

Time Frame

5 weeks

Title

Cmax of BAY1161116

Description

Cmax: maximum observed drug concentration

Time Frame

5 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Berlin GmbH

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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