ACTRN12622000171718已完成1 期
A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of GDD3898 Topical Gel in Over-weight or Obese Subjects with Presumed Nonalcoholic Fatty Liver Disease (NAFLD)
ipidio Pharmaceuticals Australia Pty Ltd.0 个研究点目标入组 21 人开始时间: 2022年2月2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
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1.Man or woman 18 to 60 years of age at the time of consent.
- •2.Body mass index (BMI) >/= 27.0 and < /= 41.0 kg/m2 at screening.
- •3.Alanine aminotransferase (ALT) >/= 30 IU/mL.
- •4.MRI-PDFF value of 6% or higher.
- •5.Women of childbearing potential are required to use a protocol-approved highly effective contraceptive method for at least 4 weeks prior to screening until at least 4 weeks after the last application.
- •6. Males with female partners of childbearing potential must use reliable forms of contraception from screening to 4 weeks after the end of treatment.
- •7.Willingness to undergo skin biopsies of the thigh(s).
排除标准
- •1.Subject is a woman who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- •2.Subject has a history of skin disease or presence of skin condition (e.g., atopic dermatitis, psoriasis, etc.) that, in the opinion of the Investigator, would interfere with the study assessments.
- •3.Subject has had corneal or eyelid surgery, such as eyelid repair, reconstruction, and/or lifts, corneal transplantation, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy, and/or radial keratotomy surgery, and/or has a history or presence of dry eye.
- •4.Subject has any history or evidence of hepatic cirrhosis and/or portal hypertension or complications (e.g. ascites, GI bleeds) or clinically meaningful hepatic impairment including:
- •a.ALT and/or AST >3 x ULN
- •b.Direct Bilirubin >/=6.9 mg/dL
- •c.Albumin < 3.6 g/dL
- •d.INR >/= 1.4
- •e.Platelets < 140 x109/mm3
- •f.FIB-4 >/= 2.67
- •g.If available, Histology: fibrosis score >/= 4 or Ishak score 5 or 6
- •h.Transient elastography >16 kPa
- •Note: Subjects with documented Gilbert’s Syndrome (elevated unconjugated hyper-bilirubinemia but normal conjugated bilirubinemia) will be allowed to participate in the study.
- •5.History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), alcoholic liver disease, or definite autoimmune liver disease.
- •6.Subject with known history of or positive results for human immunodeficiency virus (HIV).
- •7.History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening, other substance abuse within the prior two years of Screening, or positive urine drug, cotinine, or alcohol test at Screening. Significant alcohol consumption is defined as > 2 drinks/day or > 14 drinks/week for men and > 1 drink/day or > 7 drinks/week for women.
- •8.Prior or planned (during the study period) bariatric surgery (e.g., gastric bands, gastroplasty, roux-en-Y gastric bypass) or ileal resection.
- •9.Presence of scars, birthmarks, tattoos, or excessive hair at the application site(s) that would impede the assessment of local tolerability assessments.
- •10.Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localised carcinoma in situ of the cervix may be included.
- •11.Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- •12.Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the subject at undue risk by study participation or interfere with interpretation of study results (e.g., QTcF >450 msec for men or >470 msec for women).
- •13.Subjects with uncontrolled diabetes mellitus defined as hemoglobin A1c > 8.5%, hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), or history of cardiovascular disease at Screening.
- •14.Subject has a known or suspected allergy to GDD3898 or any component of the study drug or the vehicle.
- •15.Unable to refrain from or anticipates the use of:
- •a.Any drugs known to be moderate/strong inhibitors of CYP3A4 enzymes (such as boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavi
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