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Evaluate the Safety & Assess Local and Systemic PK of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women

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ClinicalTrials.gov Identifier: NCT02877979
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Tracking Information
First Submitted Date  ICMJE July 25, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date August 24, 2017
Actual Study Start Date  ICMJE November 18, 2015
Actual Primary Completion Date August 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
To evaluate the safety of three escalating doses of DS003 (1 mg, 3 mg and 10 mg), administered in a vaginal tablet formulation, to healthy, HIV-negative female volunteers. [ Time Frame: 12 weeks ]
Gynaecological assessments, including pelvic examination and colposcopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
To assess the local (vaginal fluids) and systemic (plasma) DS003 PK profile and the 24 hour cervical tissue concentration when administered in three escalating doses of a vaginal tablet formulation. [ Time Frame: 12 weeks ]
Measurement of DS003 concentrations in plasma, vaginal fluids and cervical tissue collected at various time points after administration of the vaginal tablet(s).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety & Assess Local and Systemic PK of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women
Official Title  ICMJE A Double-blind, Randomised, Placebo-controlled, Dose Escalation Trial to Evaluate the Safety and to Assess Local and Systemic Pharmacokinetics of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women
Brief Summary A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to healthy HIV-negative women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: DS003 vaginal tablet
    The trial will be conducted in three cohorts of 12 women each. In each cohort, participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17. In each cohort, therefore, 9 participants will receive DS003 vaginal tablets and 3 participants will receive placebo vaginal tablets.
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: DS003 vaginal tablet
    participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17.
    Intervention: Drug: DS003 vaginal tablet
  • Placebo Comparator: placebo
    participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 26, 2016
Actual Primary Completion Date August 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women must meet all of the following criteria to be eligible for enrolment:

  1. Women ≥ 18 and ≤ 45 years of age who can give written informed consent
  2. BMI of ≥ 18 and < 30 kg/m2
  3. Vital signs within normal limits and no clinically significant ECG findings
  4. Available for all visits and consent to follow all procedures scheduled for the trial
  5. Healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia and trichomonas) and laboratory evaluations for haematology and biochemistry
  6. HIV-negative as determined by an HIV test at the time of screening
  7. On a stable form of contraception, defined as:

    • A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR
    • Transdermal contraceptive patch for at least 3 months prior to enrolment, OR
    • Subcutaneous implant inserted at least 3 months prior to enrolment, OR
    • Long-acting progestins for at least 2 consecutive injections, OR An IUD inserted (with no vaginal or gynaecological complaints associated with its use) at least 3 months prior to enrolment, OR
    • Have undergone surgical sterilisation at least 3 months prior to enrolment AND be willing to use oral contraceptives if necessary to delay menstruation while taking part in the trial
  8. Upon pelvic examination and colposcopy at screening and visual inspection of the cervix at the time of enrolment, the cervix and vagina appear normal as determined by the Investigator
  9. Asymptomatic for urogenital infections at the time of screening (if a woman is diagnosed with any curable STI, either clinically or by laboratory test at the time of screening, she must complete the full course of treatment and have a healthy genital tract before being considered for potential re-screening)
  10. Willing to refrain from the use of topical vaginal medications, vaginal products or objects, including tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for 7 days prior to enrolment and for the duration of the trial
  11. Documentation of no abnormality on cervical cytology, including grossly bloody smear, within 90 days prior to screening
  12. Willing to refrain from participation in any other research trial for the duration of this trial
  13. Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures, e.g. by home visit or telephone, or via family or close neighbour contacts (confidentiality to be maintained)
  14. Willing to agree to abstain from all the following for a total of 2 days (48 hours) prior to each trial visit, and for a total of 3 days (72 hours) after the biopsy procedure:

    Penile-vaginal intercourse

    • Oral contact with her genitalia

  15. Hepatitis B and C negative at the time of screening

Exclusion Criteria:

Women who meet any of the exclusion criteria below are not eligible:

  1. Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
  2. Currently breast-feeding
  3. Currently or within 2 months of participation in any other clinical research trial involving investigational or marketed products prior to screening
  4. Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, prior to enrolment
  5. Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
  6. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
  7. Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
  8. Cervical cytology at screening that requires cryotherapy, biopsy, treatment, or further evaluation
  9. Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
  10. Any Grade 2, 3 or 4 haematology, biochemistry or urinalysis laboratory abnormality at baseline (screening) according to the current version of the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
  11. Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
  12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
  13. Any serious acute, chronic or progressive disease (e.g. any known history of neoplasm, cancer, diabetes, epilepsy, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition
  14. Have undergone a hysterectomy
  15. History of drug or substance abuse within 1 year of enrolment
  16. Use of tobacco within 6 months of enrolment
  17. Not willing to abstain from alcohol from 14 days prior to enrolment until completion of trial participation
  18. Have had significant blood loss, or have donated or received one or more units of blood within 6 weeks prior to enrolment
  19. Have a positive urine drug or positive breath alcohol screen at screening or enrolment
  20. Any disease or condition (medical or surgical) that might compromise haematological, cardiovascular, pulmonary, renal, gastrointestinal, or central nervous system function; or any other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the investigational product, or that would place the participant at increased risk, as determined by the Investigator
  21. Regular use of, or have received, any concomitant prescription, over-the-counter, or herbal medications or nutritional supplements within 14 days prior to enrolment
  22. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02877979
Other Study ID Numbers  ICMJE IPM 042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party International Partnership for Microbicides, Inc.
Study Sponsor  ICMJE International Partnership for Microbicides, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account International Partnership for Microbicides, Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP