ISRCTN59912845已完成1 期
An open label, single-dose, single-period study designed to assess the mass balance recovery, metabolite profile and metabolite identification of [14C]encaleret in healthy male subjects
Calcilytix Therapeutics, Inc., a BridgeBio Company0 个研究点目标入组 8 人开始时间: 2023年3月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- 性别
- Male
入选标准
- •1. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in the whole study
- •3. Must be willing to consume the drug dose, which contains a small amount of alcohol and is radiolabelled with 14C
- •4. Aged 40 to 65 years inclusive at the time of signing informed consent
- •5. Must agree to adhere to the contraception requirements defined in the clinical protocol
- •6. Healthy males as assessed by the investigator
- •7. Body mass index (BMI) of 18.0 to 35.0 kg/m² as measured at screening
- •8. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day)
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease (especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease or Irritable Bowel Syndrome), neurological or psychiatric disorder, as judged by the investigator
- •4. History of GI surgery (with the exception of appendectomy unless it was performed within the previous 12 months)
- •5. Acute diarrhoea or constipation in the 7 days before the predicted Day 1. If screening occurs >7 days before the Day 1, this criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- •6. Subject has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold
- •7. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •8. Evidence of current SARS-CoV-2 infection within 4 weeks of IMP administration
- •9. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed
- •10. Subjects with corrected Ca above the upper limit of the normal reference range
- •11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •12. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
- •13. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •14. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- •15. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •16. Subjects who are taking, or have taken, any prescribed or over-the-counter medication or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration. COVID-19 vaccines are accepted concomitant medications up to 72 h before dosing. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study
- •17. Subjects who have had a COVID-19 vaccine within 72 h before dosing
- •18. History of any drug or alcohol abuse in the past 2 years
- •19. Regular alcohol consumption in males >21 units per wee
研究者
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