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Trial record 47 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

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

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: BAY1161116 Drug: Placebo Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 27, 2017
Actual Primary Completion Date : September 8, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BAY1161116
Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
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: Itraconazole
Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Placebo Comparator: Placebo
Placebo Dose 1 to 6 of BAY 1161116
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




Primary Outcome Measures :
  1. Incidence of TEAEs [ Time Frame: 5 weeks ]
    TEAEs: treatment-emergent adverse events

  2. Severity of TEAEs [ Time Frame: 5 weeks ]
    TEAEs: treatment-emergent adverse events

  3. AUC of BAY1161116 [ Time Frame: 5 weeks ]
    AUC: Area under the concentration vs. time curve from zero to infinity

  4. Cmax of BAY1161116 [ Time Frame: 5 weeks ]
    Cmax: maximum observed drug concentration



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119077


Locations
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Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03119077     History of Changes
Other Study ID Numbers: 18752
2016-003520-23 ( EudraCT Number )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
PCOS

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors