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

NCT03102489 | Completed Phase 1

• 1 other identifier: BP101-HV02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoactive Sexual Desire Disorder(HSDD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• BP101 maximum plasma concentration (Cmax)

  Day 1

• BP101 area under the concentration versus time curve (AUC)

  Day 1

• BP101 time to maximum plasma concentration (Tmax)

  Day 1

• BP101 half-life time (T1/2)

  Day 1

• Change from Baseline in Female Sexual Function Index score

  2 weeks

Study Arms (2)

BP101

EXPERIMENTAL

Treatment with BP101

Drug: BP101

Placebo

PLACEBO COMPARATOR

Treatment with placebo

Drug: Placebo

Interventions

BP101 DRUG

Nasal spray

BP101

Placebo DRUG

Nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female healthy volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ivix LLX: lead

Study Sites (1)

Research center Eco-Safety LLC

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Daniil Nemenov, M.D.

  Ivix LLX

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: April 5, 2017
• Study Start: February 22, 2017
• Primary Completion: June 21, 2017
• Study Completion: September 19, 2017
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)