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临床试验/ACTRN12620000573954
ACTRN12620000573954已完成1 期

The Relative Oral Bioavailability of a Tablet Formulation vs a Solutionof PLN-74809 in Healthy Participants

Pliant Therapeutics, Inc.0 个研究点目标入组 24 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
24

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
Open (masking not used)

入排标准

年龄范围
18 Years 至 55 Years(—)
性别
All

入选标准

  • 1. 18 to 55 years
  • 2. Good general health, with no significant medical history and no clinically significant
  • abnormalities at screening and/or before administration of the initial dose of study drug.
  • 3. Body weight greater than or equal to 50 kg at the Screening Visit.
  • 4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
  • 5. Participants must use adequate contraception for male and female participants of childbearing potential.
  • 6. Understand the study procedures and agrees to participate in the study by giving written informed consent.

排除标准

  • - History of clinically significant abnormalities or diseases.
  • - Pregnant or lactating females.
  • - Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
  • - Positive toxicology screening panel
  • - History of substance abuse or dependency or history of recreational drug use.
  • - Alcohol consumption greater than 14 drinks per week for males (7 for females).
  • - Smokers or ‘vapers’ (cigarette or other modalities).
  • - Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements.
  • - Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study.
  • - Have participated in any other investigational drug trial within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.

研究者

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