Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

NCT ID: NCT01812889

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2).

Detailed Description

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2).

Conditions

Vaginal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 2

10 women diagnosed with BV, 10 diagnosed with VVC will be randomized to receive either TOL-463 gel or TOL-463 ovules administered intravaginally once daily for 7 consecutive days

Group Type: ACTIVE_COMPARATOR

TOL-463 Vaginal ovule

Intervention Type: DRUG

TOL-463 Vaginal Ovule

TOL-463 Vaginal gel

Intervention Type: DRUG

TOL-463 Vaginal Gel

Part 1

20 Healthy women randomized, two-way crossover design will receive a single dose of TOL-463 gel and ovule intravaginally, separated by a minimum of 7 day washout period between administrations

Group Type: ACTIVE_COMPARATOR

TOL-463 Vaginal ovule

Intervention Type: DRUG

TOL-463 Vaginal Ovule

TOL-463 Vaginal gel

Intervention Type: DRUG

TOL-463 Vaginal Gel

Interventions

TOL-463 Vaginal ovule

TOL-463 Vaginal Ovule

Intervention Type: DRUG

TOL-463 Vaginal gel

TOL-463 Vaginal Gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult women of any race between 18 to 45 years of age (inclusive).
• Subjects must be able to give voluntary written informed consent before any study related procedure is performed.
• Subjects must have a negative serum pregnancy test at Screening and negative urine pregnancy test at all other clinical site visits, as applicable.
• Subjects either have no childbearing potential (as defined below) (Note 1) or agree to avoid becoming pregnant from the day of screening through one month after the last study Day using one of the following acceptable methods of birth control (Note 2) in addition to the use of non-lubricated condoms by the male partner (even if vasectomized).

• Hormonal contraceptives
• Abstinence
• Note 1: Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy or status after hysterectomy.
• Note 2: Intravaginal or intra-uterine contraceptives and contraceptive devices (IUDs) are not acceptable forms of birth control for this study.
• Subjects must agree to refrain from douching or using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, etc.) or IUDs during the study period.
• Subjects must agree not to donate blood during the study and up to 14 days after the end of the study.
• Subjects willing and able to comply with all study requirements.

For Part 1 Only

• Subjects must be healthy as determined by medical history, physical examination, vital signs, pelvic examination and laboratory evaluations (hematology, clinical chemistry and urinalysis tests) within study-defined ranges at Screening.
• Subjects must be without current symptomatic or asymptomatic bacterial vaginosis, candida vulvovaginitis or any other form of vaginitis by clinical and microbiologic testing.
• Subjects must be willing to abstain from sexual intercourse for 24 hours prior to each site visit.

For Part 2 Only

• Subjects with vaginitis must be otherwise healthy based on medical history, physical examination, vital signs, pelvic examination and laboratory evaluations (hematology, clinical chemistry and urinalysis tests) within study-defined ranges at Screening.
• Subjects with vaginitis must be willing to abstain from sexual intercourse 24 hours prior to the first dose of study medication and throughout the last visit of the study.

Exclusion Criteria

• A history of clinically significant acute illness (resolved within 4 weeks of screening) or any other condition which, in the opinion of the Site Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
• Subjects with intrauterine devices.
• Subjects with renal dysfunction (serum creatinine >/= 1.2 mg/dL).
• Subjects with underlying metabolic or endocrine dysfunction, such as diabetes mellitus, Cushing's disease, Addison's disease, or hypo- or hyperthyroidism.
• Subjects who test positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
• Subjects who have diseases known to cause immunodeficiency, e.g., AIDS, advanced malignancy, anemia or severe vitamin deficiency.
• Subjects who test positive for Trichomonas vaginalis, Neisseria gonorrhea, or Chlamydia trachomatis at screening.
• Subjects with active genital lesions at screening, including syphilitic chancre, herpetic lesions, or genital warts (HPV).
• Subjects who have had major surgery within 4 weeks of screening.
• Subjects with an uncontrolled active illness (e.g., active infection) or fever (oral temperature >/=100 degrees F or >/= 37.7 degrees C) at screening.
• Subjects with a known sensitivity to any ingredient in TOL-463 vaginal gel or ovule.
• With the exception of oral contraceptives, use of a prescription medication, notably antimicrobial agents, corticosteroids or other immuno-suppressants, within 14 days prior to Day 1 of study treatment, unless in the opinion of the PI, the substance would not likely impact the conduct or results of this study.
• Subjects with any current unstable medical condition(s) requiring prescription medication(s) that would preclude accurate evaluation of subjects or otherwise impact the conduct or results of the study.
• Subjects who have received an investigational drug in a clinical trial within 30 days prior to screening.
• Women who are pregnant or breast feeding. Subject has a positive history for alcohol abuse or dependence and/or a positive urine screen test for alcohol and drugs of abuse [amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP)] at screening or at any check-in prior to receiving study drug.
• Subjects who have donated blood within the past 30 days prior to Day 1 of treatment with study drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quintiles Phase I Services - Overland Park

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

HHSN272200800024C

Identifier Type: -

Identifier Source: secondary_id

TOL-463

Identifier Type: -

Identifier Source: secondary_id

11-0077

Identifier Type: -

Identifier Source: org_study_id