Clinical trial NCT03102489: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypoactive Sexual Desire Disorder(HSDD)
Lead sponsor: Ivix LLX
Sponsor class: INDUSTRY
First posted: 2017-04-05
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of treatment-emergent Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: BP101 maximum plasma concentration (Cmax)
timeFrame: Day 1
measure: BP101 area under the concentration versus time curve (AUC)
timeFrame: Day 1
measure: BP101 time to maximum plasma concentration (Tmax)
timeFrame: Day 1
measure: BP101 half-life time (T1/2)
timeFrame: Day 1
measure: Change from Baseline in Female Sexual Function Index score
timeFrame: 2 weeks
measure: Change from Baseline in Female Sexual Function Index score
timeFrame: 6 weeks
measure: Change from Baseline in Female Sexual Distress Scale-Revised score
timeFrame: 2 weeks
measure: Change from Baseline in Female Sexual Distress Scale-Revised score
timeFrame: 6 weeks
measure: Change from Baseline in Female Sexual Function questionnaire score
timeFrame: 2 weeks
measure: Change from Baseline in Female Sexual Function questionnaire score
timeFrame: 6 weeks
measure: Change from Baseline in Arizona Sexual Experience Scale score
timeFrame: 2 weeks
measure: Change from Baseline in Arizona Sexual Experience Scale score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Research center Eco-Safety LLC
Study officials:
affiliation: Ivix LLX
name: Daniil Nemenov, M.D.
role: STUDY_DIRECTOR
References: