A Safety and Tolerability Study of Administration of PSD502

NCT01183208 | Completed Phase 1

• 1 other identifier: PSD502-PE-006
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Evaluation of adverse events, serious adverse events, findings from the examination of the cervix and vagina, vital signs, electrocardiogram data, hematology, and biochemistry parameters

  Throughout the study

Secondary Outcomes (2)

• Pharmacokinetic parameters: AUC0-t, AUC0-inf, AUCtau, Rc, Cmax, tmax, t½ and kel

  Days 1 through 7

• Vaginal fluid analysis for active ingredients and metabolites

  Days 2 and 5

Study Arms (3)

Cohort 1 active treatment and placebo

EXPERIMENTAL

Active treatment and placebo

Drug: Intervention A; Drug: Intervention D

Cohort 2 - Active treatment and placebo

EXPERIMENTAL

Active treatment and placebo

Drug: Intervention B; Drug: Intervention D

Cohort 3 Active Treatment and placebo

EXPERIMENTAL

Active treatment and placebo

Drug: Intervention C; Drug: Intervention E

Interventions

Intervention A DRUG

A single dose of 3 mg will consist of 3 sprays of the 1 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)

Cohort 1 active treatment and placebo

Intervention B DRUG

A single dose of 30 mg will consist of 3 sprays of the 10 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)

Cohort 2 - Active treatment and placebo

Intervention C DRUG

A single dose of 150 mg will consist of 15 sprays of the 10 mg strength spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)

Cohort 3 Active Treatment and placebo

Intervention D DRUG

A dose of placebo will consist of 3 sprays of the placebo spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)

Cohort 1 active treatment and placebo; Cohort 2 - Active treatment and placebo

Intervention E DRUG

A dose of placebo will consist of 15 sprays of the placebo spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)

Cohort 3 Active Treatment and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female non-smokers aged 18 years old and over
• Willing and able to provide written informed consent
• Generally, in good health in the opinion of the investigator
• Subject must have a body mass index between 18 and 30 kg/m2, inclusive
• Willing and able to comply with all study procedures in the opinion of the investigator
• Negative Papanicolaou smear performed either during gynaecological examination at screening or documented in the 12 months prior to study entry
• Negative drugs of abuse and cotinine test at screening
• Female subjects of child-bearing potential who are sexually active or become sexually active must be using a method of effective contraception from 14 days before screening and continue to use this until the end of the study (If oral contraceptives are used, these must have been stable for a period of 3 months. If a barrier method is being used, this should be latex based and not polyurethane based)
• Female subjects who are post-menopausal must have been post-menopausal \>1 year and have confirmed elevated serum follicle stimulating hormone at screening

You may not qualify if:

• History of a significant medical condition that would preclude further study participation, in the opinion of the investigator
• Currently taking, or has taken within the 2 weeks prior to screening, any concomitant medication that could confound interpretation of the safety or pharmacokinetic data on PSD502. Use of prescription medication within 14 days or over-the-counter products within 7 days prior to first dose
• Suffering from an sexually transmitted disease, or is positive for hepatitis B, hepatitis C, or human immunodeficiency virus infection
• Safety testing: abnormalities at screening, in particular liver function tests, which are indicative of a medical condition and that would preclude further participation, in the opinion of the investigator
• Significant abnormality of the vaginal mucosa or cervix that would preclude interpretation of the examination of these areas or that could be worsened by use of PSD502
• History of alcohol or drug abuse within 1 year prior to screening
• Known drug sensitivity to amide-type local anaesthetics
• Unlikely to understand or be able to comply with study procedures, for any reason, in the opinion of the investigator
• History of glucose-6-phosphate dehydrogenase deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g., anti-malarial agents)
• Use of class I (e.g., mexiletine, tocainide) and III (e.g., amiodarone, sotalol) anti-arrhythmic drugs
• Subject has received an investigational (non-registered) drug within 90 days of screening
• Subject has any physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
• Uro-gynaecological disease or recent surgery within 8 weeks of screening which would make intravaginal application or vaginal examination/colposcopy difficult or painful OR
• Ongoing significant psychiatric disorder (e.g., bipolar disease, depression/anxiety disorder or schizophrenia)
• Subject has a clinically obvious vaginal infection, such as active vaginal Candida albicans (thrush), or other abnormal vaginal discharge

Sponsors & Collaborators

• Plethora Solutions Ltd: lead
• Bio-Kinetic Europe, Ltd.: collaborator
• Omnicare Clinical Research: collaborator

Study Sites (1)

Bio-Kinetic Europe Limited

Belfast, BT2 7BA, United Kingdom

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: August 17, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

GB (1)