A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a single-center, non-randomized, open-label, parallel-controlled study designed to evaluate the pharmacokinetic profile and safety of D-2570 in participants with hepatic impairment and those with normal hepatic function. Participants with hepatic impairment will be enrolled first, followed by participants with normal hepatic function.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前:Huan Zhou
- 電話番号:+86 0552-3085747
- メール:zhouhuanbest@vip.163.com
研究場所
-
-
Anhui
-
Bengbu、Anhui、中国、233004
- 募集
- The First Affiliated Hospital of Bengbu Medical University
-
コンタクト:
- Huan Zhou
- 電話番号:+86 0552-3085747
- メール:zhouhuanbest@vip.163.com
-
-
参加基準
適格基準
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:
- Voluntarily participate in this study and sign the written informed consent form after full informed consent, and agree to comply with the procedures specified in the study protocol.
- Aged 18 to 70 years.
- Both males and females are eligible.
- Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
- Participants with normal hepatic function must have adequate hematologic, renal, and hepatic function.
- Have no plan to reproduce or donate sperm/eggs from screening until 30 days after the last dose of study drug, and agree to either completely abstain from sexual intercourse or use effective contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.
Exclusion Criteria:
- Have undergone any prior surgery that may affect drug absorption, distribution, metabolism, or excretion, which, in the opinion of the investigator, would make the participant unsuitable for enrollment.
- Are female and currently lactating, or have a positive serum pregnancy test result at screening or during the study period.
- Have a known history of drug or substance abuse, or test positive for drugs of abuse on the urine drug screen.
- Have participated in another interventional clinical trial within 3 months prior to screening, or are currently participating in another clinical trial (participants who withdraw from a prior trial before treatment, i.e., were not randomized or did not receive study intervention, may be enrolled in this study).
- Have received a live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
- Have any other condition or finding that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.
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)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:D-2570 Group 1
D-2570 Group 1 |
D-2570 tablet, administered orally as a single dose |
|
実験的:D-2570 Group 2
D-2570 Group 2 |
D-2570 tablet, administered orally as a single dose |
|
実験的:D-2570 Group 3
D-2570 Group 3 |
D-2570 tablet, administered orally as a single dose |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
時間枠:Up to 192 hours after the last dose
|
The main PK parameters -Time to maximum measured plasma concentration -Tmax |
Up to 192 hours after the last dose
|
|
Maximum observed plasma concentration-Cmax
時間枠:Up to 192 hours after the last dose
|
Maximum observed plasma concentration-Cmax |
Up to 192 hours after the last dose
|
|
The main PK parameters Half-life -t1/2
時間枠:Up to 192 hours after the last dose
|
The main PK parameters Half-life -t1/2 |
Up to 192 hours after the last dose
|
|
The main PK parameters#Area under the plasma concentration versus time curve-AUC
時間枠:Up to 192 hours after the last dose
|
The main PK parameters#Area under the plasma concentration versus time curve-AUC |
Up to 192 hours after the last dose
|
|
The main PK parameters-CL/F (apparent clearance)
時間枠:Up to 192 hours after the last dose
|
The main PK parameters-CL/F (apparent clearance) |
Up to 192 hours after the last dose
|
|
The main PK parameters-Vz/F (apparent volume of distribution)
時間枠:Up to 192 hours after the last dose
|
The main PK parameters-Vz/F (apparent volume of distribution) |
Up to 192 hours after the last dose
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events
時間枠:Up to Day9
|
Incidence of adverse events |
Up to Day9
|
協力者と研究者
捜査官
捜査官
- 主任研究者:Huan Zhou、The First Affiliated Hospital of Bengbu Medical University
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- D2570-106
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
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