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临床试验/ISRCTN24987553
ISRCTN24987553已完成1 期

A phase I, randomized, open-label, active-controlled, three-way treatment trial assessing pharmacokinetics, bioavailability and safety of two single doses of CAM2038 (Buprenorphine FluidCrystal® Injection Depot) q4w (once monthly) and four repeat doses of CAM2038 q1w (once weekly) versus active comparators, intravenous and sublingual buprenorphine, in healthy volunteers under naltrexone blockage

Camurus AB (Sweden)0 个研究点目标入组 57 人开始时间: 2014年7月29日最近更新:
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试验速览

阶段
1 期
状态
已完成
发起方
入组人数
57
研究概览入排标准研究者记录与标识符相似试验

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Are able to provide written informed consent to participate in the trial and able to understand the procedures and trial requirements.
  • •2. Are healthy adult male or female, = 18 and = 65 years of age at the time of signing of informed consent (asthma in childhood is acceptable).
  • •3. Body mass index (BMI) range of 18.5 to 30.0 kg/m2, inclusive, and body weight of at least 50 kg.
  • •4. If female, is non-lactating and non-pregnant (has negative pregnancy test results at Screening).
  • •5. If female, is of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control and agrees to continue with the regimen throughout the trial:
  • •5.1. Oral, implantable, or injectable contraceptives for 3 consecutive months before Screening, in combination with a condom.
  • •5.2. Intrauterine device (IUD) in combination with a condom.
  • •5.3. Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal gels or cream).
  • •6. Are willing and able to comply with the trial requirements and complete the trial assessments.
  • •7. Are willing to abstain from activities that require focused attention, e.g., driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance during the study).

排除标准

  • •1. Have a known contraindication or hypersensitivity to buprenorphine or other opioids, confirmed at screening visit.
  • •2. Have any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies), confirmed at screening visit.
  • •3. Have any clinically significant laboratory test result (at screening) that contraindicates trial participation.
  • •4. Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinology, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the investigator (confirmed at screening).
  • •5. Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole, antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) (confirmed at screening).
  • •6. Current dependence (by DSM-IV criteria) of any psychoactive substance other than opiates or caffeine dependence (confirmed at screening).
  • •7. Prior or current enrolment in an opiate-substitution or addiction rehabilitation program (i.e., methadone, levo-alpha-acetylmethadol) (confirmed at screening).
  • •8. Subject has a positive serology test for hepatitis B surface antigen, hepatitis C virus antibodies, or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at screening.
  • •9. Are considered by the Investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator?s Brochure for CAM2038 q1w and CAM2038 q4w [buprenorphine FluidCrystal® injection depot]), to be an unsuitable candidate to receive the trial medication (confirmed at screening).
  • •10. Have any other condition or deviation that, in the Investigator?s opinion, makes the subject unsuitable for participation in the trial (confirmed at screening).
  • •11. Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other studies under the direction of the Investigator or trial site, or is a family member of an employee or of the Investigator (confirmed at screening).
  • •12. Veins unsuitable for venipuncture.
  • •13. Any condition requiring regular concomitant medication including herbal products, or predicted need of any concomitant medication during the study (confirmed at screening).
  • •14. Intake of any medication (except paracetamol [up to 2 g per day]) including over-the-counter (OTC) medication, herbal and dietary supplements such as St John?s Wort, vitamins and minerals that could affect the outcome of the study, within 2 weeks before the first administration of the IMP or less than 5 times the half-life of that medication, whichever is the longer.
  • •15. Subject has a pulse of < 40 bpm or > 90 bpm; mean SBP < 90 mmHg or > 140 mmHg; mean DBP < 40 mmHg or > 90 mmHg (measurements taken in triplicate at screening after subject has been resting in supine position for at least 5 minutes; pulse will be measured automatically).
  • •16. Subject has orthos

研究者

发起方
Camurus AB (Sweden)

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