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

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ClinicalTrials.gov Identifier: NCT03102489
Recruitment Status : Active, not recruiting
First Posted : April 5, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Ivix LLX

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

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder(HSDD) Drug: BP101 Drug: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : June 21, 2017
Estimated Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: BP101
Treatment with BP101
Drug: BP101
Nasal spray
Placebo Comparator: Placebo
Treatment with placebo
Drug: Placebo
Nasal spray



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. BP101 maximum plasma concentration (Cmax) [ Time Frame: Day 1 ]
    To determine pharmacokinetic parameter of maximum plasma concentration (Cmax) after single administration of BP101 in healthy volunteers.

  2. BP101 area under the concentration versus time curve (AUC) [ Time Frame: Day 1 ]
    To determine pharmacokinetic parameter area under the plasma concentration versus time curve (AUC) after single administration of BP101 in healthy volunteers.

  3. BP101 time to maximum plasma concentration (Tmax) [ Time Frame: Day 1 ]
    To determine pharmacokinetic parameter time to maximum plasma concentration (Tmax) after single administration of BP101 in healthy volunteers.

  4. BP101 half-life time (T1/2) [ Time Frame: Day 1 ]
    To determine pharmacokinetic parameter of plasma half-life time (T1/2) after single administration of BP101 in healthy volunteers.

  5. Change from Baseline in Female Sexual Function Index score [ Time Frame: 2 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).

  6. Change from Baseline in Female Sexual Function Index score [ Time Frame: 6 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).

  7. Change from Baseline in Female Sexual Distress Scale-Revised score [ Time Frame: 2 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).

  8. Change from Baseline in Female Sexual Distress Scale-Revised score [ Time Frame: 6 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).

  9. Change from Baseline in Female Sexual Function questionnaire score [ Time Frame: 2 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.

  10. Change from Baseline in Female Sexual Function questionnaire score [ Time Frame: 6 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.

  11. Change from Baseline in Arizona Sexual Experience Scale score [ Time Frame: 2 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.

  12. Change from Baseline in Arizona Sexual Experience Scale score [ Time Frame: 6 weeks ]
    To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female healthy volunteers
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102489


Locations
Russian Federation
Research center Eco-Safety LLC
Saint Petersburg, Russian Federation
Sponsors and Collaborators
Ivix LLX
Investigators
Study Director: Daniil Nemenov, M.D. Ivix LLX

Responsible Party: Ivix LLX
ClinicalTrials.gov Identifier: NCT03102489     History of Changes
Other Study ID Numbers: BP101-HV02
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders