A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Pimodivir
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.
详细描述
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of JNJ-63623872 in combination with oseltamivir in participants with influenza A infection. The study consists of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and follow up Phase (21 Days). The duration of participation in the study for each participant is approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
- •Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
- •Participants must be capable of swallowing study medication tablets and capsules
- •Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- •Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
排除标准
- •Participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
- •Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
- •Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
- •Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
- •Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
研究组 & 干预措施
JNJ-63623872 plus Oseltamivir
Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
干预措施: JNJ-63623872 (Drug)
JNJ-63623872 plus Oseltamivir
Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
干预措施: Oseltamivir (Drug)
Placebo plus Oseltamivir
Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
干预措施: Placebo (Drug)
Placebo plus Oseltamivir
Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years).
Minimum Observed Plasma Concentration (Cmin) of Pimodivir
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
次要结局
- Percentage of Participants With Influenza Complications(Up to 28 Days)
- Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score(Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33)
- Time to Improvement of Respiratory Status(Up to 28 Days)
- Time to Return to Premorbid Functional Status(Up to Day 33)
- Time to Influenza A Viral Negativity(Up to 14 Days)
- Time to Improvement of Vital Signs(Up to 28 Days)
- Percentage of Participants With Clinical Outcome Based on Ordinal Scale(Day 8)
- Time to Significant Reduction in FLU-PRO Influenza Symptom Severity(Up to Day 33)
- Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)(Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 and 33)
- Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir(Up to 28 Days)
- Time to Hospital Discharge(Up to 28 Days)
- Time to Return to Usual Health(Up to Day 33)
- Influenza Viral Load Over Time(Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14)
- Rate of Decline in Viral Load(Up to Day 7)
- Area Under the Plasma Concentration-time Curve (AUC) of Viral Load(Baseline up to Day 8)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)(Up to 28 Days)