CLINICAL TRIALS PROFILE FOR MANOGEPIX
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Clinical Trials for Manogepix
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT04148287 ↗ | An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris | Terminated | Amplyx Pharmaceuticals | Phase 2 | This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C. auris in patients aged 18 years and over with limited antifungal treatment options. |
| NCT04148287 ↗ | An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris | Terminated | Pfizer | Phase 2 | This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C. auris in patients aged 18 years and over with limited antifungal treatment options. |
| NCT04166669 ↗ | A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 | Completed | Amplyx Pharmaceuticals | Phase 1 | This is a Phase 1, open-label study to evaluate the drug-drug interaction potential of a strong CYP3A4 inhibitor (itraconazole) and a pan-CYP inducer (rifampin) on APX001 in two parallel groups of healthy subjects. |
| NCT04166669 ↗ | A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 | Completed | Pfizer | Phase 1 | This is a Phase 1, open-label study to evaluate the drug-drug interaction potential of a strong CYP3A4 inhibitor (itraconazole) and a pan-CYP inducer (rifampin) on APX001 in two parallel groups of healthy subjects. |
| NCT04240886 ↗ | Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds | Recruiting | Amplyx Pharmaceuticals | Phase 2 | This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi). |
| NCT05421858 ↗ | A Study to Learn About the Study Medicine (Called Fosmanogepix/ PF-07842805) in People With Candidemia and/or Invasive Candidiasis. | Not yet recruiting | Pfizer | Phase 3 | The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking participants who have a diagnosis of candidemia or invasive candidiasis. Two-thirds of all participants will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all participants will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules. Fosmaogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmaogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if participants are well enough to be discharged from the hospital. We will compare the experience of people receiving fosmanogepix to those receiving caspofungin/ fluconazole. This will help us determine if fosmanogepix is safe and effective. Participants will continue treatment for a maximum of 6 weeks depending on whether the infection has cleared and whether the symptoms related to the infection has improved. During this time, they will have study visits for up to 10 times. There will also be a follow-up visit 4 weeks after the study treatment was stopped. |
| NCT05491733 ↗ | A Bioequivalence Study of APX001 High-load and Low-load Tablets | Completed | Pfizer | Phase 1 | A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Manogepix
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