NCT03102489CompletedPhase 1
Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
Ivix LLX1 site in 1 country18 target enrollmentStarted: February 22, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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^
- •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.
Arms & Interventions
BP101
Experimental
Treatment with BP101
Intervention: BP101 (Drug)
Placebo
Placebo Comparator
Treatment with placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-emergent Adverse Events
Time Frame: 6 weeks
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 Outcomes
- BP101 half-life time (T1/2)(Day 1)
- Change from Baseline in Female Sexual Function questionnaire score(6 weeks)
- BP101 maximum plasma concentration (Cmax)(Day 1)
- Change from Baseline in Female Sexual Distress Scale-Revised score(6 weeks)
- Change from Baseline in Female Sexual Function Index score(6 weeks)
- BP101 area under the concentration versus time curve (AUC)(Day 1)
- BP101 time to maximum plasma concentration (Tmax)(Day 1)
- Change from Baseline in Arizona Sexual Experience Scale score(6 weeks)
Investigators
Study Sites (1)
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