NL-OMON20539Not yet recruitingNot Applicable
An open-label study to assess the pharmacokinetics and safety/tolerability of pulsatile intra-vaginal delivery of a single dose of oxybutynin in healthy females
iGalli BV0 sites8 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 8
Study Overview
Brief Summary
.A.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Willing to give written informed consent and willing and able to comply with the study protocol;
- •2. Female subjects of child bearing potential (women of child bearing potential, WOCBP) aged between 18 and 45 years (inclusive)
- •Female postmenopausal subjects aged between 50 and 69 years (inclusive); Postmenopausal status is defined as age = 50 years and having > 12 months amenorrhoea in the absence of hormonal therapy that may cause amenorrhoea.
- •3. Subject is in good general health, according to the investigator’s judgement based on vital signs, medical history, physical examination, and laboratory tests performed.
- •4. Body mass index between 18-32 kg·m2 (inclusive) and with a minimum body weight of 50 kg at screening
- •5. Ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions
- •6. Using contraceptives of second generation containing ethinylestradiol and progesterone derivate (WOCBP subjects only). This includes a hormone-containing IUD (e.g. Mirena), second generation oral contraceptive pill, hormonal contraception using parenteral medroxyprogesteron or subcutaneous etonogestrel.
Exclusion Criteria
- •1. (A history of) any clinically significant medical condition or abnormalities, as judged by the investigator, in physical examination, laboratory test results (including chemistry panel with hepatic and renal panels, complete blood count, and urine dipstick) or electrocardiography (ECG). In the case of uncertain or questionable results,
- •tests performed during screening may be repeated to confirm eligibility or judged by the investigator to be clinically irrelevant for healthy subjects.
- •2. Being a virgin.
- •3. History of sexual abuse/violence.
- •4. First day of last withdrawal bleeding <10 days before Day 0
- •5. Plan to discontinue oral contraceptive during study period.
- •6. Positive pregnancy test at screening or at baseline prior to IMP administration and/or lactating.
- •7. Having given birth vaginally or by caesarean section 6 months prior to screening
- •8. Having had sexual intercourse or objects inserted vaginally that could potentially lacerate or damage the vaginal wall 24 hours prior to dosing.
- •9. Positive screening test for Hepatitis B/C and/or Human Immunodeficiency Virus (HIV) test at screening
- •10. Positive screening PCR test for Chlamydia trachomatis or gonorrhea at screening
- •11. Medical history of intra- and/or transvaginal operations that in the opinion of the investigator may interfere with placement or stability of the MedRing or absorption of the IMP. Exceptions may include endometrial curettage for e.g. miscarriage or abortion or LIS-excision of the cervix for CIN if performed > 3 months prior to screening.
- •12. High risk for sexual transmitted diseases (STD) (a. 3 or more different sexual contacts in last 6 months, and/or b. is a sex worker or visits them and/or c. has a partner with an STD risk as described (a. and/or b.), and/or d. partner is a male who has sex with male).
- •13. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against oxybutynin, or multiple drug allergies (non-active hay fever is acceptable).
- •14. Participation in any marketed or investigational drug or device study within 3 months or 5 half-lives (whichever is longer) prior to first dosing.
- •15. Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 21 days prior to study drug administrations, or less than five half-lives (whichever is longer, and during the course of the study). Exceptions are the incidental use of OTC medications paracetamol (up to 4 g/day) and ibuprofen (up to 1 g/day) which are allowed within two days of clinical
- •Assessments.
- •16. Use of alcohol during the 24 hours prior to screening and/or an unwillingness to abstain from alcohol consumption during the stay at the clinical unit, and for at least 24 hours prior to each study visit;
- •17. Positive urine drug screen or alcohol test at screening and/or at study days.
- •18. Intake of grapefruit or grapefruit juice within 5 days of IMP administration, and/or unwillingness to abstain from the consumption of these products from 5 days prior to IMP administration until the last study visit;
- •19. Loss or donation of blood over 500 mL within four months prior to screening.
- •20. Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.
Investigators
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