A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
A Phase 1, Non-randomized, Open-label, Multi-center Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Fosmanogepix in Adult Subjects With End-stage Renal Disease Requiring Intermittent Hemodialysis
This study will evaluate how fosmanogepix is processed by the body (pharmacokinetics, PK) in participants with kidney failure (end-stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) compared with participants with normal kidney function (control group). Fosmanogepix is given by intravenous infusion and is converted in the body to manogepix, the active form of the drug. Fosmanogepix is an investigational and has not been approved by the United States Food and Drug Administration (FDA) or any other regulatory authority for use in humans.
The study will also evaluate the effect of hemodialysis on manogepix levels in participants with ESRD.
The safety and tolerability of fosmanogepix will also be assessed in participants with kidney failure and in matched participants with normal kidney function.
Participation in the study will last up to 11 weeks and will include up to two study periods. Participants with ESDR requiring IHD will receive fosmanogepix in two study periods. Healthy participants will receive fosmanogepix in one study period.
The study will be conducted at two study sites in the United States.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
アクセスの拡大
連絡先と場所
研究連絡先
- 名前:Thomas Kaindl, MD
- 電話番号:+41615671505
- メール:thomas.kaindl@basilea.com
研究場所
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Florida
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Orlando、Florida、アメリカ、32809
- 募集
- Orlando Clinical Research Center
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Tampa、Florida、アメリカ、33603
- 募集
- Genesis Clinical Research
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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 of 18 to 42 kg/m2, inclusive, and a total body weight > 50 kg at Screening.
- Subjects with normal renal function only: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min
- Subjects with ESRD requiring IHD only: Hemodialysis treatment for at least 3 months prior to Screening, with dialysis performed ≥ 3 times per week and adequate dialysis efficiency as established by document Kt/V ≥ 1.2 on current regimen. The clinical status of the underlying ESRD should be stable
Exclusion Criteria:
- Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study.
- Laboratory abnormality or other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, that may increase the risk to study participation, or in the Investigator's judgment, make the subject inappropriate for the study.
- History or presence of clinically-significant disorders, which, in the opinion of the Investigator, are capable of significantly altering the distribution, metabolism, or elimination of the study drug.
- Renal or liver transplant recipients
- Hepatic impairment not related to ESRD
- Use of any prohibited medication within five half-lives plus 14 days prior to Day -1
Subjects with ESRD requiring IHD only:
-Not on stable dosing regimen (i.e., < 3 weeks prior to Screening) of prescription/ non prescription drugs (including dietary/herbal supplements) for the treatment of a stable concomitant disease
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 |
|---|---|
|
実験的:Period 1 and Period 2
Participants with end stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) |
Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2. Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2 in each period (Period 1 and 2) |
|
実験的:Period 1
Participants with normal renal function (control group) |
Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2. Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2 in each period (Period 1 and 2) |
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 |
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of manogepix
時間枠:Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
Cmax of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1. |
Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
|
Area under the concentration-time curve (AUC) of manogepix
時間枠:Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
AUC of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1. |
Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
|
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2
時間枠:Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2 will be assessed after fosmanogepix IV administration in subjects with ESRD requiring IHD. |
Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
|
Impact of IHD on the Tmax of manogepix (total and unbound) Periods 1 and 2
時間枠:Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
Impact of IHD on the Tmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in subjects with ESRD requiring IHD. |
Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
|
Impact of IHD on the Cmax of manogepix (total and unbound) Periods 1 and 2
時間枠:Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
Impact of IHD on the Cmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in participants with ESRD requiring IHD. |
Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants reporting treatment emergent adverse events (TEAEs)
時間枠:From screening to up to 35 days after last study drug administration.
|
To evaluate the safety and tolerability of fosmanogepix in participants with ESRD requiring IHD, and in healthy participants. |
From screening to up to 35 days after last study drug administration.
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Thomas Kaindl, MD、Basilea Pharmaceutica International Ltd, Allschwil
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- FMGX-CP-111
- 75A50124C00033 (その他の助成金/資金番号:BARDA)
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?
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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