stop_circleTerminated/Withdrawn

Polycystic ovary syndrome

Bayer Identifier:

18752

ClinicalTrials.gov Identifier:

NCT03119077

EudraCT Number:

2016-003520-23

EU CT Number:

Not Available
Single ascending dose, First-in-Human study on safety, tolerability and pharmacokinetics of BAY1161116

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years
  • - 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)
  • - 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

Trial summary

Enrollment Goal
32
Trial Dates
April 2017 - January 2018
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1161116
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Terminated
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • Incidence of TEAEs
    TEAEs: treatment-emergent adverse events
    date_rangeTime Frame:
    5 weeks
  • Severity of TEAEs
    TEAEs: treatment-emergent adverse events
    date_rangeTime Frame:
    5 weeks
  • AUC of BAY1161116
    AUC: Area under the concentration vs. time curve from zero to infinity
    date_rangeTime Frame:
    5 weeks
  • Cmax of BAY1161116
    Cmax: maximum observed drug concentration
    date_rangeTime Frame:
    5 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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