A randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover proof of concept study of intradermally administered desmopressin in healthy volunteers using a nanoporous microneedle array.
- Conditions
- Route of administration
- Registration Number
- NL-OMON48081
- Lead Sponsor
- MyLife Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1. Healthy male or non-pregnant female subjects, 18 to 65 years of age
(inclusive). (Healthy status is defined by absence of evidence of any clinical
significant/uncontrolled active or chronic disease following a detailed medical
and surgical history, a complete physical examination including vital
signs,12-lead ECG, hematology, blood chemistry, serology and urinalysis);
2. Free of any polyuric disease (e.g., central diabetes insipidus), hemophilia
or Von Willebrand disease;
3. Body mass index (BMI) between 18 and 35 kg/m2, inclusive;
4. Free of clinically significant systemic or dermatologic disorders, which, in
the opinion of the investigator, will interfere with the study results or
increase the risk of Adverse Events;
5. If female of childbearing potential have a negative urine pregnancy test at
Screening/Day 0, and is willing to use effective contraception during the study
(i.e., oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation,
abstinence, or are in a monogamous relationship with a partner who has had a
vasectomy);
6. Suitable site for intradermal injection, patch application on the arms, as
assessed by the investigator;
7. Fitzpatrick skin type I-II (Caucasian);
8. Able to participate and willing to give written informed consent and to
comply with the study restrictions;
9. Ability to communicate well with the investigator in the Dutch language;
Eligible subjects must meet none of the following exclusion criteria:
1. Any clinically significant abnormality as determined by medical history
taking and physical examinations obtained during the screening visit that in
the opinion of the investigator would interfere with the study objectives or
compromise subject safety;
2. Not willing to use effective (double barrier) contraception until at least 3
months after last study drug application;
3. For women: a positive pregnancy test and/or breastfeeding at screening or
women who plan to become pregnant;
4. A positive test for drugs of abuse at screening;
5. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol
consumption > 21 units/week);
6. Positive test results for Hepatitis B, Hepatitis C or HIV;
7. Have any current and / or recurrent clinical significant skin infection in
the treatment area;
8. Have a known sensitivity to any of the investigational product ingredients;
9. Participation in an investigational drug or device study within 3 months
prior to screening or more than 4 times in the past year;
10. Donation of blood or blood loss of >500 mL within 3 months prior to
screening or donation of plasma within 14 days;
11. Not having a general practitioner;
12. Not willing to give permission to have the general practitioner to be
notified upon participation in this study;
13. Any condition that in the opinion of the investigator would complicate or
compromise the study or the well-being of the subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety endpoints<br /><br>Adverse events (AE) will be collected throughout the study, at every study<br /><br>visit. Vital signs and ECGs will be performed at every study visit. Urine<br /><br>collection for volume and osmolality will be collected during all treatment<br /><br>visits.<br /><br><br /><br>Tolerability endpoints<br /><br>- Visual analogue scale for pain (VAS)<br /><br>ID administration vs. IM administration, vs. IV administration vs.<br /><br>patch administration<br /><br>- Examination of injection site by physician (erythema, swelling)<br /><br>- Grading for itching, pain<br /><br>- Skin barrier integrity by TEWL<br /><br>- Morphology by optical coherence tomography (OCT)<br /><br><br /><br>Pharmacokinetic endpoints<br /><br>- Absolute Bioavailability<br /><br>- Maximum concentration<br /><br>- Time to maximum concentration<br /><br>- Plasma half-life<br /><br>- Area under the curve (AUC(0-24h), AUC(0-last))</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>