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Clinical Trials/NL-OMON51105
NL-OMON51105CompletedNot 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 - PK of intra-vaginal oxybutynin

iGalli BV0 sites8 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •Eligible subjects must meet all of the following inclusion criteria at
  • •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

  • •Eligible subjects must meet none of the following exclusion criteria at
  • •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
  • •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
  • •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
  • •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 in

Investigators

Sponsor
iGalli BV

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