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

NCT03119077 | Terminated Phase 1

• 2 other identifiers: 187522016-003520-23
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (4)

• Incidence of TEAEs

  TEAEs: treatment-emergent adverse events

  5 weeks

• Severity of TEAEs

  TEAEs: treatment-emergent adverse events

  5 weeks

• AUC of BAY1161116

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

  5 weeks

• Cmax of BAY1161116

  Cmax: maximum observed drug concentration

  5 weeks

Study Arms (2)

BAY1161116

EXPERIMENTAL

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

Drug: BAY1161116; Drug: Itraconazole

Placebo

PLACEBO COMPARATOR

Placebo Dose 1 to 6 of BAY 1161116

Drug: Placebo; Drug: Itraconazole

Interventions

BAY1161116 DRUG

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

BAY1161116

Placebo DRUG

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

Placebo

Itraconazole DRUG

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

BAY1161116; Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: April 27, 2017
• Primary Completion: September 8, 2017
• Study Completion: January 31, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

DE (1)