NL-OMON51108已完成不适用
An open-label, crossover study to assess the pharmacokinetics, safety and tolerability of pulsatile intra-vaginal delivery of insulin aspart in females with diabetes mellitus type 1 - PK of intra-vaginal insulin
iGalli BV0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Eligible subjects must meet all 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 with diabetes mellitus type 1 of childbearing potential
- •(women of childbearing potential, WOCBP) aged between 18 and 45 years
- •(inclusive).
- •3. Subject is on insulin therapy under multiple daily injection (MDI) or
- •continuous subcutaneous insulin infusion (CSII).
- •4. Subject is on continuous glucose monitoring (CGM) with a CGM device or a
- •flash monitoring device (e.g. Abbott Freestyle Libre) more than 24 hours in
- •5. Subject is in good general health (apart from T1DM), according to the
- •investigator*s judgement based on vital signs, medical history, physical
- •examination, and laboratory tests performed.
- •6. Body mass index between 18-32 kg*m2 (inclusive) and with a minimum body
- •weight of 50 kg at screening.
- •7. Ability to communicate well with the investigator in the Dutch language and
- •willing to comply with the study restrictions.
- •8. Using contraceptives of second generation containing ethinylestradiol and
- •progesterone derivate. This includes a hormone-containing IUD (e.g. Mirena),
- •second generation oral contraceptive pill, hormonal contraception using
- •parenteral medroxyprogesteron or subcutaneous etonogestrel.
排除标准
- •Eligible subjects must meet none of the following exclusion criteria at
- •1. (A history of) any clinically significant medical condition or abnormality,
- •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) at screening. 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. Patients on (hybrid) closed loop systems, i.e. Medtronic 670G/780 pump.
- •3. Patients with unstable glucose regulation in opinion of the investigators,
- •for example frequent hypo- or hyperglycemia or with hypoglycemia unawareness.
- •4. Being a virgin.
- •5. History of sexual abuse/violence.
- •6. First day of last withdrawal bleeding <10 days before both study days.
- •7. Plan to discontinue oral contraceptive during study period.
- •8. Positive pregnancy test at screening or at baseline prior to IMP
- •administration and/or lactating.
- •9. Having given birth vaginally or by caesarean section 6 months prior to
- •10. Having had sexual intercourse or objects inserted vaginally that could
- •potentially lacerate or damage the vaginal wall 24 hours prior to dosing.
- •11. Positive screening test for Hepatitis B/C and/or Human Immunodeficiency
- •Virus (HIV) test at screening.
- •12. Positive screening PCR test for Chlamydia trachomatis or gonorrhoea at
- •13. 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.
- •14. 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.
- •15. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against insulin aspart (Fiasp), or multiple drug allergies (non-active hay
- •fever is acceptable).
- •16. Participation in any marketed or investigational drug or device study
- •within 3 months or 5 half-lives (whichever is longer) prior to first dosing.
- •17. Use of prescription medication or any other substance that in the opinion
- •of the investigators may influence the outcome of the study (e.g. systemic
- •steroids) 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.
- •18. 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.
- •19. Positive urine drug screen or alcohol test at screening and/or at study
- •20. Loss or donation of blood over 500 mL within four months
研究者
相似试验
进行中（未招募）
1 期
Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.Pulmonary arterial hypertensionEUCTR2018-002448-10-ATBial - Portela & Ca, S.A.40
进行中（未招募）
1 期
Multi centre study to assess the safety, effective and movement of Zamicastat within the body when given to a patient with pulmonary arterial hypertension as an additional medication.Pulmonary arterial hypertensionMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2018-002448-10-GBBial - Portela & Ca, S.A32
进行中（未招募）
1 期
Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.Pulmonary arterial hypertensionEUCTR2018-002448-10-ESBial - Portela & Ca, S.A.40
进行中（未招募）
1 期
Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.Pulmonary arterial hypertensionEUCTR2018-002448-10-ITBIAL-Portela & Ca, S.A.40
进行中（未招募）
1 期
Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2018-002448-10-PTBial - Portela & Ca, S.A.40