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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Rozszerzony dostęp
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Thomas Kaindl, MD
- Numer telefonu: +41615671505
- E-mail: thomas.kaindl@basilea.com
Lokalizacje studiów
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-
Florida
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Orlando, Florida, Stany Zjednoczone, 32809
- Rekrutacyjny
- Orlando Clinical Research Center
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Tampa, Florida, Stany Zjednoczone, 33603
- Rekrutacyjny
- Genesis Clinical Research
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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) |
|
Eksperymentalny: 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) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of manogepix
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of participants reporting treatment emergent adverse events (TEAEs)
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Thomas Kaindl, MD, Basilea Pharmaceutica International Ltd, Allschwil
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- FMGX-CP-111
- 75A50124C00033 (Inny numer grantu/finansowania: BARDA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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