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

Tracking Information

• First Submitted Date: April 13, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: May 17, 2018
• Actual Study Start Date: April 27, 2017
• Actual Primary Completion Date: September 8, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Polycystic Ovary Syndrome

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 21, 2017): 32
• Original Estimated Enrollment (submitted: April 13, 2017): 48
• Actual Study Completion Date: January 31, 2018
• Actual Primary Completion Date: September 8, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03119077
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Bayer
• Study Sponsor: Bayer
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: May 2018