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

NCT ID: NCT03102489

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2017-09-19

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.

Conditions

Hypoactive Sexual Desire Disorder(HSDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BP101

Treatment with BP101

Group Type: EXPERIMENTAL

BP101

Intervention Type: DRUG

Nasal spray

Placebo

Treatment with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Nasal spray

Interventions

BP101

Nasal spray

Intervention Type: DRUG

Placebo

Nasal spray

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ivix LLX

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniil Nemenov, M.D.

Role: STUDY_DIRECTOR

Ivix LLX

Locations

Research center Eco-Safety LLC

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

BP101-HV02

Identifier Type: -

Identifier Source: org_study_id