2023-504780-17-00
已完成
1 期
A Phase 1 Open-label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Obeldesivir in Participants With Normal Renal Function and Renal Impairment
概览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Plasma PK parameters Cmax, AUClast, and AUCinf of GS-441524 (ODV metabolite)
概览
简要总结
To evaluate the single-dose pharmacokinetic of Obeldesivir in participants with renal impairment relative to matched control participants with normal renal function
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •All Participants Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures.
- •Must have an eGFRCKD-EPI,creatinine at screening of: 60 ≤ eGFRCKD-EPI,creatinine < 90 mL/min/1.73 m2 for mild disease (Cohort 3a) or 30 ≤ eGFRCKD-EPI,creatinine < 60 mL/min/1.73 m2 for moderate disease (Cohort 1a) or 15 ≤ eGFRCKD-EPI,creatinine < 30 mL/min/1.73 m2 for severe disease (Cohort 2a).
- •Have hepatic transaminase (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 2 x upper limit of normal (ULN) at screening and at admission.
- •Matched Control Participants In addition to the criteria listed above, matched control participants must also meet the following additional inclusion criteria to be eligible for participation in this study: Must have an eGFRCKD-EPI,creatinine of ≥ 90 mL/min/1.73 m2 at screening.
- •Must match in gender, age (± 10 years), and BMI (± 20%) with the respective participant in the RI group (Cohorts 1a, 2a, and 3a). Note: Participants with normal renal function can serve as a control for both mild and moderate RI cohorts, as long as the matching criteria are met, but may only serve as a matched control to one renal impaired participant within a cohort.
- •Have ALT and AST at or below the ULN at screening and at admission.
- •Be aged 18 through 79 years, inclusive, at screening and at admission.
- •Have a calculated BMI of at least 18.0 and no greater than 38.0 kg/m2 at screening.
- •Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception as described in Appendix 11.
- •Have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following study drug administration.
排除标准
- •All Participants Positive serum pregnancy test at screening and at admission (Appendix 11.4). Admission urine pregnancy test can be performed in addition to, but not in place of, admission serum pregnancy test when expedited serum pregnancy test results are unavailable.
- •Have a history of any of the following: a) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria. b) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatotoxicity). c) Known hypersensitivity to the study drug, its metabolites, or to formulation excipients (see Section 5). d) Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with lef+C12t ventricular ejection fraction ≤ 40%); or a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years. e) Syncope, palpitations, or unexplained dizziness. f) Implanted defibrillator or pacemaker. g) Liver disease, including Gilbert syndrome. h) Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (≥ 6 months) medical treatment. i) Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary.
- •Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.6.
- •Participants With Impaired Renal Function: Participants with RI requiring or anticipated to require dialysis within 6 months of dosing are not eligible.
- •Matched Control Participants: Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to study drug administration, with the exception of vitamins, and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
- •Have any serious or active medical illness that, in the opinion of the investigator, would interfere with participant treatment, assessment, or compliance with the protocol. This would include cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), and immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
- •Breastfeeding participant.
- •Participants who plan to donate sperm from clinic admission (ie, Day −1) throughout the study period, and through the required contraception period as described in Appendix 11.
- •Have received any study drug within 30 days prior to study dosing.
- •Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission.
结局指标
主要结局
Plasma PK parameters Cmax, AUClast, and AUCinf of GS-441524 (ODV metabolite)
Plasma PK parameters Cmax, AUClast, and AUCinf of GS-441524 (ODV metabolite)
次要结局
- Incidence of AEs and laboratory abnormalities.
- Urine concentrations of GS-441524 (ODV metabolite) and its urine PK parameters (Ae, CLr, and %Fe).
研究者
EU CT Support
Scientific
Gilead Sciences Inc.
研究点 (1)
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