A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants
An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in Adult Participants
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Florida
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Orlando、Florida、アメリカ、32809
- Orlando Clinical Research Center
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Texas
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San Antonio、Texas、アメリカ、78215
- The Texas Liver Institute
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Body mass index (BMI) (kilograms [kg]/height [m]^2) between 18.0 and 38.0 kilogram/meter^2 (kg/m2) (inclusive), and body weight not less than (<) 50 kg
Participants with normal renal function:
- Have normal renal function defined as estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter/minute computed with the online calculator on the CKD-EPI website by use of the Chronic Kidney Disease Epidemiology Collaboration creatinine clearance (CKD-EPIcr) result
- Must have stable renal function as defined as: (a) for participants with impaired renal function: <20 percent (%) change in serum creatinine concentrations between screening and Day -1; (b) for healthy participants: a change in serum creatinine concentration <0.2 milligram per deciliter (mg/dL) between screening and Day -1
Participants with renal impairment:
- Have an impaired renal function based on eGFR as(eGFR computed with the online calculator on the CKD-EPI website providing eGFR (in mL/min units) by use of the CKD-EPIcr result: (a) eGFR <90 to 60 mL/minute for participants in Group 3 (mild renal impairment cohort); (b) eGFR 30 to 59 mL/minute for participants in Group 4 (moderate renal impairment cohort); (c) eGFR <30 mL/minute but not yet on hemodialysis, for participants in Group 1 (severe renal impairment and/or kidney failure); (d) eGFR <15 mL/minute and on hemodialysis, for participants in Group 5 (kidney failure)
- Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 months (3 months for thyroid hormone replacement therapy [HRT]) before dosing as well as during the study
Exclusion Criteria:
- Individuals who take creatine supplements, have a non-standard muscle mass such as amputation, malnutrition, or muscle wasting; because these factors are not accounted for in the prediction equations for GFR chronic kidney disease epidemiology collaboration (CKD EPI)
Participants with normal renal function:
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1, as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, body temperature, or 12 lead ECG at screening or Day -1, as deemed appropriate by the investigator
Participants with renal impairment:
- Evidence of clinically apparent concurrent disease based upon complete clinical laboratory testing, full physical examination, or medical history, except for controlled hypertension and those problems directly associated with the primary diagnosis of renal impairment
- Any clinically significant laboratory abnormality except abnormalities that may be caused by renal impairment
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Part A: Group 1
Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter[mL]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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アクティブコンパレータ:Part A: Group 2
Healthy participants with normal renal function (eGFR greater than or equal to [>=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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実験的:Part B: Group 3 (Optional)
Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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実験的:Part B: Group 4 (Optional)
Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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実験的:Part B: Group 5 (Optional)
Participants with kidney failure (eGFR: <15 mL/minute and on hemodialysis; pharmacokinetic [PK] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Maximum Observed Plasma Analyte Concentration (Cmax)
時間枠:Up to Day 29
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Cmax is defined as the maximum observed plasma analyte concentration.
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Up to Day 29
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Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)
時間枠:Up to Day 29
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Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
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Up to Day 29
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Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])
時間枠:Up to 24 hours postdose
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AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.
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Up to 24 hours postdose
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Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])
時間枠:Up to 144 hours postdose
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AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.
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Up to 144 hours postdose
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Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])
時間枠:Up to Day 29
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AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
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Up to Day 29
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Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])
時間枠:Up to Day 29
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AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.
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Up to Day 29
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Total Apparent Oral Clearance (CL/F)
時間枠:Up to Day 29
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CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).
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Up to Day 29
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Apparent Volume of Distribution (Vd/F)
時間枠:Up to Day 29
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Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].
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Up to Day 29
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Apparent Terminal Elimination Rate Constant (Lambda[z])
時間枠:Up to Day 29
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Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.
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Up to Day 29
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Apparent Terminal Elimination Half-life (t1/2)
時間枠:Up to Day 29
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t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).
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Up to Day 29
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Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)
時間枠:Up to Day 7
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Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).
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Up to Day 7
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Renal Clearance (CLr)
時間枠:Up to 144 hours postdose
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CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).
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Up to 144 hours postdose
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
安全性と忍容性の尺度としての有害事象のある参加者の数
時間枠:最大8週間
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有害事象とは、治験薬を投与された参加者に発生するあらゆる不都合な医学的事象であり、必ずしも当該治験薬との因果関係が明らかな事象のみを指すものではありません。
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最大8週間
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CR108802
- 56136379HPB1010 (その他の識別子:Janssen Research & Development, LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
JNJ-56136379の臨床試験
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Janssen Sciences Ireland UC完了B型肝炎、慢性ベルギー, アメリカ, 日本, 大韓民国, フランス, 香港, カナダ, イタリア, タイ, ドイツ, マレーシア, スペイン, ロシア連邦, 七面鳥, イギリス, ポーランド, ブラジル, チェコ, 中国
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Janssen Sciences Ireland UC完了B型肝炎、慢性ベルギー, イギリス, フランス, イタリア, ドイツ, スペイン, ポーランド
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Janssen Sciences Ireland UC完了B型肝炎アメリカ, 大韓民国, フランス, ベルギー, イタリア, 台湾, イギリス, タイ, マレーシア, 中国, スペイン, カナダ, ドイツ, 日本, ロシア連邦, 七面鳥, ウクライナ, ポーランド, 香港
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Janssen Sciences Ireland UC完了健康 | 肝炎、慢性フランス, 台湾, スペイン, ベルギー, ブルガリア, マレーシア, ルーマニア, ドイツ, グルジア, モルドバ共和国
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Ottawa Hospital Research Instituteわからない
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Janssen Research & Development, LLC完了B型肝炎、慢性フランス, 台湾, カナダ, アメリカ, ドイツ, スペイン, 日本, ロシア連邦, 七面鳥, イギリス
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Janssen Research & Development, LLC完了B型肝炎フランス, アメリカ, ベルギー, イギリス, ポーランド, ニュージーランド, ドイツ, イタリア, カナダ