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

Completed

• Conditions: NA; pharmacokinetics of oxybutynin; 10004994

• Registration Number: NL-OMON51105
• Lead Sponsor: iGalli BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Eligible subjects must meet all of the following inclusion criteria at
screening:
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)
OR
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
screening:
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 in

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK parameters by non-compartmental analysis of the plasma concentration-time<br /><br>data:<br /><br>* AUCinf, AUClast, Cmax, tmax, t1/2, tlag, CL/F, Vz/F<br /><br>* Dose-normalized PK parameters: AUCinf, AUClast, Cmax</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at<br /><br>every study visit<br /><br>* Anticholinergic side effect (pupil size, salivary flow, visual near point<br /><br>acuity and pulse rate) per assessment schedule<br /><br>* Concomitant medication throughout the study at every study visit<br /><br>* Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic<br /><br>blood pressure (mmHg)) as per assessment schedule<br /><br>* Physical examination including in speculum examination per assessment<br /><br>schedule</p><br>