Back to resultsSafety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers
Primary Purpose
Hypoactive Sexual Desire Disorder(HSDD)
Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
BP101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disorder(HSDD)
Eligibility Criteria
Inclusion Criteria:
- Healthy women aged from 18 to 40, inclusive.
- Verified diagnosis "healthy": absence gastrointestinal, hepatic, renal, cardiovascular, endocrine, central nervous system, ear, nose, throat (ENT) and gynecological disorders (performed standard clinical, laboratory and instrumental assessments did not reveal any disorders).
- Body mass index (BMI) within range from 18.5 to 30 kg/m^2.
- Subject consent not to intake alcohol during the entire study period; negative alcohol breath test at screening and before start of Investigational Product administration.
- Negative pregnancy test result at screening and before start of Investigational Product administration.
- Consent to use adequate methods of contraception throughout the study.
- Normal regular menstrual cycle of 28 +/- 7 days duration for at least 6 months before study enrollment.
- Women with stable sexual partner.
Exclusion Criteria:
- Chronic cardiovascular, respiratory, neuroendocrine, genitourinary systems disorders, as well as gastrointestinal, hepatic, renal, blood, and ENT disorders (including acute and chronic rhinitis, sinusitis, and others).
- Gynecological disorders (polycystic ovary syndrome, mommas, endometriosis, inflammatory diseases and others).
- Positive cervical cytology Papanicolaou (PAP) test in medical anamnesis within 12 months before screening.
- Lab abnormalities (blood hematology and biochemistry and urinalysis) at screening.
- Electrocardiogram (ECG) abnormalities at screening, and before start of Investigational Product administration.
- Systolic blood pressure in a sitting position below 100 mm Hg or above 140 mm Hg; and/or diastolic pressure below 60 mm Hg or above 90 mm Hg at screening and before start of Investigational Product administration.
- Heart rate less than 60 beats/min or more than 90 beats/min at screening, and before start of Investigational Product administration.
- Signs of malignant neoplasms in medical history, during the examination at any time prior to start of Investigational Product administration.
- Psychiatric disorders (including any form of schizophrenia, epilepsy, bipolar affective disorder and others), intake of psychotropic agents.
- Chronic pain syndromes (including chronic pelvic pain syndrome).
- Acute infections within 4 weeks before screening.
- Regular intake of medications (including nonprescription drugs, vitamins, and Supplements) within 2 weeks before screening.
- Intake of more than 5 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 liter of beer, 200 ml wine or 30 ml of spirit (pure alcohol)) or historical information about alcoholism, substance abuse, prescription drug abuse.
- Smoking more than 10 cigarettes a day.
- Pregnancy or breastfeeding, positive urine pregnancy at screening and before the start of Investigational Product administration.
Sites / Locations
- Research center Eco-Safety LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BP101
Placebo
Arm Description
Treatment with BP101
Treatment with placebo
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent Adverse Events
To evaluate frequency, seriousness, and severity of adverse events, including events of dose-limiting toxicity in healthy volunteers receiving different doses of BP101 compared to placebo after multiple administrations.
Secondary Outcome Measures
BP101 maximum plasma concentration (Cmax)
To determine pharmacokinetic parameter of maximum plasma concentration (Cmax) after single administration of BP101 in healthy volunteers.
BP101 area under the concentration versus time curve (AUC)
To determine pharmacokinetic parameter area under the plasma concentration versus time curve (AUC) after single administration of BP101 in healthy volunteers.
BP101 time to maximum plasma concentration (Tmax)
To determine pharmacokinetic parameter time to maximum plasma concentration (Tmax) after single administration of BP101 in healthy volunteers.
BP101 half-life time (T1/2)
To determine pharmacokinetic parameter of plasma half-life time (T1/2) after single administration of BP101 in healthy volunteers.
Change from Baseline in Female Sexual Function Index score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Change from Baseline in Female Sexual Function Index score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Change from Baseline in Female Sexual Distress Scale-Revised score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Change from Baseline in Female Sexual Distress Scale-Revised score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Change from Baseline in Female Sexual Function questionnaire score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Change from Baseline in Female Sexual Function questionnaire score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Change from Baseline in Arizona Sexual Experience Scale score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Change from Baseline in Arizona Sexual Experience Scale score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03102489
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers
Official Title
Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
September 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivix LLX
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.
Detailed Description
Double-blind, randomized, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BP101 after multiple doses administration in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder(HSDD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BP101
Arm Type
Experimental
Arm Description
Treatment with BP101
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo
Intervention Type
Drug
Intervention Name(s)
BP101
Intervention Description
Nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nasal spray
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent Adverse Events
Description
To evaluate frequency, seriousness, and severity of adverse events, including events of dose-limiting toxicity in healthy volunteers receiving different doses of BP101 compared to placebo after multiple administrations.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
BP101 maximum plasma concentration (Cmax)
Description
To determine pharmacokinetic parameter of maximum plasma concentration (Cmax) after single administration of BP101 in healthy volunteers.
Time Frame
Day 1
Title
BP101 area under the concentration versus time curve (AUC)
Description
To determine pharmacokinetic parameter area under the plasma concentration versus time curve (AUC) after single administration of BP101 in healthy volunteers.
Time Frame
Day 1
Title
BP101 time to maximum plasma concentration (Tmax)
Description
To determine pharmacokinetic parameter time to maximum plasma concentration (Tmax) after single administration of BP101 in healthy volunteers.
Time Frame
Day 1
Title
BP101 half-life time (T1/2)
Description
To determine pharmacokinetic parameter of plasma half-life time (T1/2) after single administration of BP101 in healthy volunteers.
Time Frame
Day 1
Title
Change from Baseline in Female Sexual Function Index score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Time Frame
2 weeks
Title
Change from Baseline in Female Sexual Function Index score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Time Frame
6 weeks
Title
Change from Baseline in Female Sexual Distress Scale-Revised score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Time Frame
2 weeks
Title
Change from Baseline in Female Sexual Distress Scale-Revised score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Time Frame
6 weeks
Title
Change from Baseline in Female Sexual Function questionnaire score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Time Frame
2 weeks
Title
Change from Baseline in Female Sexual Function questionnaire score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Time Frame
6 weeks
Title
Change from Baseline in Arizona Sexual Experience Scale score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Time Frame
2 weeks
Title
Change from Baseline in Arizona Sexual Experience Scale score
Description
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female healthy volunteers
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women aged from 18 to 40, inclusive.
Verified diagnosis "healthy": absence gastrointestinal, hepatic, renal, cardiovascular, endocrine, central nervous system, ear, nose, throat (ENT) and gynecological disorders (performed standard clinical, laboratory and instrumental assessments did not reveal any disorders).
Body mass index (BMI) within range from 18.5 to 30 kg/m^2.
Subject consent not to intake alcohol during the entire study period; negative alcohol breath test at screening and before start of Investigational Product administration.
Negative pregnancy test result at screening and before start of Investigational Product administration.
Consent to use adequate methods of contraception throughout the study.
Normal regular menstrual cycle of 28 +/- 7 days duration for at least 6 months before study enrollment.
Women with stable sexual partner.
Exclusion Criteria:
Chronic cardiovascular, respiratory, neuroendocrine, genitourinary systems disorders, as well as gastrointestinal, hepatic, renal, blood, and ENT disorders (including acute and chronic rhinitis, sinusitis, and others).
Gynecological disorders (polycystic ovary syndrome, mommas, endometriosis, inflammatory diseases and others).
Positive cervical cytology Papanicolaou (PAP) test in medical anamnesis within 12 months before screening.
Lab abnormalities (blood hematology and biochemistry and urinalysis) at screening.
Electrocardiogram (ECG) abnormalities at screening, and before start of Investigational Product administration.
Systolic blood pressure in a sitting position below 100 mm Hg or above 140 mm Hg; and/or diastolic pressure below 60 mm Hg or above 90 mm Hg at screening and before start of Investigational Product administration.
Heart rate less than 60 beats/min or more than 90 beats/min at screening, and before start of Investigational Product administration.
Signs of malignant neoplasms in medical history, during the examination at any time prior to start of Investigational Product administration.
Psychiatric disorders (including any form of schizophrenia, epilepsy, bipolar affective disorder and others), intake of psychotropic agents.
Chronic pain syndromes (including chronic pelvic pain syndrome).
Acute infections within 4 weeks before screening.
Regular intake of medications (including nonprescription drugs, vitamins, and Supplements) within 2 weeks before screening.
Intake of more than 5 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 liter of beer, 200 ml wine or 30 ml of spirit (pure alcohol)) or historical information about alcoholism, substance abuse, prescription drug abuse.
Smoking more than 10 cigarettes a day.
Pregnancy or breastfeeding, positive urine pregnancy at screening and before the start of Investigational Product administration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniil Nemenov, M.D.
Organizational Affiliation
Ivix LLX
Official's Role
Study Director
Facility Information:
Facility Name
Research center Eco-Safety LLC
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers
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