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

February 10, 2020 updated by: Ivix LLX

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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).
2 weeks
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).
6 weeks
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).
2 weeks
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).
6 weeks
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.
2 weeks
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.
6 weeks
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.
2 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ivix LLX

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daniil Nemenov, M.D., Ivix LLX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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