Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers

Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder(HSDD)
• Intervention / Treatment: Drug: BP101; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Research Center Eco-Safety LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BP101; Treatment with BP101	Drug: BP101; Nasal spray
PLACEBO_COMPARATOR: Placebo; Treatment with placebo	Drug: Placebo; Nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BP101 maximum plasma concentration (Cmax)	To determine pharmacokinetic parameter of maximum plasma concentration (Cmax) after single administration of BP101 in healthy volunteers.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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).	2 weeks
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).	6 weeks
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).	2 weeks
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).	6 weeks
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.	2 weeks
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.	6 weeks
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.	2 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: Ivix LLX
• Investigators: Study Director: Daniil Nemenov, M.D., Ivix LLX

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2017
• Primary Completion (ACTUAL): June 21, 2017
• Study Completion (ACTUAL): September 19, 2017

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: BP101-HV02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No