EUCTR2014-001446-24-DE进行中（未招募）不适用
A Phase 1, Single Dose, 4-Period Crossover Study to Assess the Bioavailability of an Mirabegron Oral Suspension Relative to the Mirabegron Prolonged Release Tablet and to Assess the Effect of Food on the Pharmacokinetics of Mirabegron Oral Suspension in Healthy Young Male and Female Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Independent Ethics Committee-approved written informed consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures(including withdrawal of prohibited medication, if applicable).
- •2. Subject is a healthy male or female subject aged 18 to less than 26 years of age at screening.
- •3. Subject has a body mass index of 18.5 to 29.9 kg/m2 inclusive.
- •4. Female subject must:
- •a) Agree not to try to become pregnant during the study and for 28 days after the final study drug administration.
- •b) Have a negative serum pregnancy test at day -1.
- •c) And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control† starting at screening and throughout the clinical study period, and for 28 days after the final study drug administration. ††
- •5. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug administration.
- •6. Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
- •7. Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit.
- •† Highly effective forms of birth control include:
- •- Consistent and correct usage of established oral contraception.
- •- Injected or implanted hormonal methods of contraception.
- •- Established intrauterine device or intrauterine system.
- •- Any male partner that has undergone effective surgical sterilization.
- •- Any female partner that has undergone effective surgical sterilization.
- •†† Barrier methods of birth control includes:
- •- Condom with spermicidal foam/gel/film/cream/suppository.
- •- Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/ cream/suppository.
- •Note: the combination of condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository is not considered as a highly effective form of birth control.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- •2. Subject has a known or suspected hypersensitivity to mirabegron or any components of the formulations used.
- •3. Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma glutamyl transferase [GGT], total bilirubin [TBL]) above 1.5 times the upper limit of normal. In such a case the assessment may be repeated once [day -1 of the first treatment period].
- •4. Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •5. Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, and/or other major disease or malignancy, as judged by the Investigator.
- •6. Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to admission to the clinical unit [day -1 of the first treatment period].
- •7. Subject has any clinically significant abnormality following the Investigator’s review of the physical examination, electrocardiogram (ECG) and clinical study protocol-defined clinical laboratory tests at screening or day -1 of the first treatment period.
- •8. Subject has a mean heart rate (HR) < 50 or > 90 beats per minute; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (vital sign measurements taken in triplicate after subject has been resting in supine position for 5 minutes; HR will be measured automatically). If the mean HR, SBP or DBP exceeds the limits above, 1 additional assessment can be taken [day -1 of the first treatment period).
- •9. Subject has a mean QTc(F) interval of > 430 ms (for males) and > 450 ms (for females) at day -1 of the first period. If the mean QTc(F) exceeds the limits above, 1 additional triplicate ECG can be taken [day -1 of the first treatment period].
- •10. Subject uses any prescribed or non-prescribed drugs (vitamins, natural and herbal remedies [e.g., St. John’s Wort]) in the 2 weeks (or 5 elimination half-lives, whichever is longer) prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day), oral contraceptives or hormone replacement therapy.
- •11. Subject consumes products containing grapefruit or Seville orange in the 2 weeks prior to study drug administration.
- •12. Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- •13. Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 14 units of alcohol for female subjects) within 3 months prior to admission to the clinical unit.
- •14. Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
- •15. Subject has significant blood loss, donated one unit (500 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit.
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