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

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ClinicalTrials.gov Identifier: NCT03119077
Recruitment Status : Terminated (Study early terminated due to lower drug exposure)
First Posted : April 18, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 13, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date May 17, 2018
Actual Study Start Date  ICMJE April 27, 2017
Actual Primary Completion Date September 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • Incidence of TEAEs [ Time Frame: 5 weeks ]
    TEAEs: treatment-emergent adverse events
  • Severity of TEAEs [ Time Frame: 5 weeks ]
    TEAEs: treatment-emergent adverse events
  • AUC of BAY1161116 [ Time Frame: 5 weeks ]
    AUC: Area under the concentration vs. time curve from zero to infinity
  • Cmax of BAY1161116 [ Time Frame: 5 weeks ]
    Cmax: maximum observed drug concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • Experimental: BAY1161116
    Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
    Interventions:
    • Drug: BAY1161116
    • Drug: Itraconazole
  • Placebo Comparator: Placebo
    Placebo Dose 1 to 6 of BAY 1161116
    Interventions:
    • Drug: Placebo
    • Drug: Itraconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 21, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
48
Actual Study Completion Date  ICMJE January 31, 2018
Actual Primary Completion Date September 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119077
Other Study ID Numbers  ICMJE 18752
2016-003520-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP