Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding
調査の概要
詳細な説明
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants.
The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study.
The end of the study will be the date of the last study visit for the last participant in the study.
The following estimates are provided:
- From first participant in to last participant out, the study is expected to take approximately one year to complete.
- The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
Florida
-
Orlando、Florida、アメリカ
- Orlando Clinical Research Center, Inc.
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ
- Davita Clinical Research
-
-
Tennessee
-
Knoxville、Tennessee、アメリカ
- New Orleans Center for Clinical Research
-
-
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:
Key Inclusion Criteria:
- Male or Female
Age, at the time of Informed Consent:
i. Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70 years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy Participants): 18 to 79 years old, inclusive
- Non-smokers and smokers who smoke no more than 10 cigarettes per day
- Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator.
For participants with hepatic impairment:
- Liver cirrhosis that has been stable;
- Platelet count >30,000 cells/millimeter cubed (mm^3);
- Total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe)
For healthy participants:
• Creatinine clearance ≥ 81 milliliter per minute (mL/min)
For participants with renal impairment:
- Must have a diagnosis of renal impairment that has been stable
- Must have renal impairment in the following categories based on creatinine clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to 29 mL/min) renal impairment
Exclusion Criteria:
Key Exclusion Criteria:
- Use of any new medication
- Human immunodeficiency virus (HIV) positive
- Presence of acute active liver disease or acute liver injury
- History of significant cardiovascular impairment
- Positive drug or alcohol test
- Weight loss or gain of >10% prior to Day 1
- Receipt of blood or blood products or donation of blood or blood products
For participants with hepatic impairment:
- History of hepatic transplant, systemic lupus erythematosus, or hepatic coma
- Received treatment with interferon or pegylated interferon
- Participants who have encephalopathy >Grade 2, sepsis, or gastrointestinal bleeding; esophageal varices >Grade 2, acute hepatic failure of any etiology, history of surgical portosystemic shunt, renal impairment (creatinine clearance <50 mL/min according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function
- Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) ≥ 100 mmHg
For healthy participants:
• Hemoglobin level less than 12.0 grams per deciliter (g/dL)
For participants with renal impairment:
- A history of renal transplant
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal impairment
- Significant bleeding diathesis
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:基礎科学
- 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 |
---|---|
他の:6 participants with mild renal impairment
Renal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min)
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:6 participants with moderate renal impairment
Renal Impairment Moderate: creatinine clearance, 30 to 49 mL/min
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:6 participants with severe renal impairment
Renal Impairment Severe: creatinine clearance, 15 to 29 mL/min
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:8 participants normal renal status
Renal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:6 participants with mild hepatic impairment
Hepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:6 participants with moderate hepatic impairment
Hepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:6 participants with severe hepatic impairment
Hepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
他の:8 participants normal hepatic status
Hepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
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 |
時間枠 |
---|---|
Number of participants with any serious adverse event and any non-serious adverse event
時間枠:1 week
|
1 week
|
協力者と研究者
スポンサー
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 (見積もり)
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
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。
Plasma Samplingの臨床試験
-
Womack Army Medical CenterUniformed Services University of the Health Sciences; The Geneva Foundation募集
-
Zimmer BiometBiomet Spain Orthopaedics S.L.終了しました
-
Belfast Health and Social Care TrustQueen's University, Belfast; NHS Blood and Transplant; Northern Ireland Clinical Trials Unit募集
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR); Stem Cell Network積極的、募集していない
-
The University of QueenslandBaxter Healthcare Corporation; Health Research Council, New Zealand; Australian Government Department...完了