临床试验/NCT06168318

NCT06168318已完成1 期

A 3-part, Phase 1, Single-center, Open-label Study to Assess the Relative Bioavailability of Oral Formulations for an Investigational Capsid Inhibitor in Healthy Adult Participants, and to Evaluate the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants

ViiV Healthcare1 个研究点分布在 1 个国家目标入组 46 人开始时间: 2023年12月18日最近更新: 2024年8月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: ViiV Healthcare
入组人数: 46
试验地点: 1
主要终点: Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants must be 18 to 55years of age.
•Participants who are overtly healthy.
•Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
•Has body mass index (BMI) within the range 19-32 (kg/m2).
•Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
•Capable of giving signed informed consent.

排除标准

•History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
•Abnormal blood pressure.
•Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
•Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
•Current or chronic history of liver disease or known hepatic or biliary abnormalities.
•Participants with exclusionary electrocardiogram findings.
•Past or intended use of exclusionary medications or vaccines.
•Exposure > 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
•ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimated serum creatinine clearance <60 mL/min.
•History of or current infection with hepatitis B or hepatitis C.
•Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
•Positive HIV antibody test.
•Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.

研究组 & 干预措施

Part 1 - Regimen A

Experimental

VH4004280 Formulation A tablet administered in fed conditions.

干预措施: VH4004280 Formulation A (Drug)

Part 1 - Regimen B

Experimental

VH4004280 Formulation B tablet administered in fed conditions.

干预措施: VH4004280 Formulation B (Drug)

Part 1 - Regimen C

Experimental

VH4004280 Formulation C tablet administered in fed conditions.

干预措施: VH4004280 Formulation C (Drug)

Part 1 - Optional Regimen D

Experimental

VH4004280 Formulation D tablet administered in fed conditions.

干预措施: VH4004280 Formulation D (Drug)

Part 1 - Optional Regimen E

Experimental

VH4004280 Formulation E tablet administered in fed conditions.

干预措施: VH4004280 Formulation E (Drug)

Part 2 - Regimen A

Experimental

VH4004280 Formulation A tablet administered in fasted conditions.

干预措施: VH4004280 Formulation A (Drug)

Part 2- Optional Regimen 1

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation B (Drug)

Part 2- Optional Regimen 1

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation C (Drug)

Part 2- Optional Regimen 1

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation D (Drug)

Part 2- Optional Regimen 1

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation E (Drug)

Part 2- Optional Regimen 2

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation B (Drug)

Part 2- Optional Regimen 2

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation C (Drug)

Part 2- Optional Regimen 2

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation D (Drug)

Part 2- Optional Regimen 2

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation E (Drug)

Part 2- Optional Regimen 3

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation B (Drug)

Part 2- Optional Regimen 3

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation C (Drug)

Part 2- Optional Regimen 3

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation D (Drug)

Part 2- Optional Regimen 3

Experimental

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

干预措施: VH4004280 Formulation E (Drug)