CLINICAL TRIALS PROFILE FOR ASP0367
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Clinical Trials for ASP0367
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03682484 ↗ | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort | Completed | Astellas Pharma Global Development, Inc. | Phase 1 | This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2). The primary purpose of this study is to evaluate the safety and tolerability of single ascending oral doses in Part 1 (SAD Including Evaluation of Food Effect) and multiple ascending oral doses in Part 2 (MAD) of MA-0211 in healthy adult participants. This study will also evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending and multiple ascending oral doses of MA-0211 in healthy adult participants. In addition, this study will evaluate the effect of a single oral dose of MA-0211 on the QT interval using Fridericia's Correction (QTcF); determine the effect of food on the PK of a single oral dose of MA-0211 as well as evaluate the effect of multiple oral doses of MA-0211 on the QTcF. |
| NCT04184882 ↗ | A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD) | Recruiting | Astellas Pharma Inc | Phase 1 | The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367. |
| NCT04641962 ↗ | A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy | Recruiting | Astellas Pharma Inc | Phase 2/Phase 3 | The purpose of the phase 2 portion of this study is to select a biologically-active ASP0367 dose level by pharmacokinetic (PK) and pharmacodynamic (PD) evaluation. The phase 2 portion of this study will also assess the safety and tolerability of ASP0367. The purpose of the phase 3 portion of this study is to assess the effect of ASP0367 on functional improvement relative to placebo and will also assess the safety and tolerability of ASP0367 relative to placebo. The phase 3 portion of this study will also assess the effect of ASP0367 on functional improvement and fatigue relative to placebo and will assess the effect of ASP0367 in overall participant functioning relative to placebo. |
| NCT04855201 ↗ | A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction | Recruiting | Astellas Pharma Global Development, Inc. | Phase 1 | The purpose of this study is to to evaluate the effect of ASP0367 on improvement of aerobic capacity relative to placebo, as well as evaluate the safety and tolerability of ASP0367 relative to placebo. This study will also evaluate the effect of ASP0367 on improvement of other aerobic capacity parameters relative to placebo, as well as evaluate the effect of ASP0367 on improvement of functional capacity relative to placebo. |
| NCT04942964 ↗ | A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function | Recruiting | Astellas Pharma Global Development, Inc. | Phase 1 | The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function. The study will also evaluate the safety and tolerability of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function. |
| NCT05117294 ↗ | A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People | Not yet recruiting | Astellas Pharma Global Development, Inc. | Phase 1 | This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different groups of people. This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups are different in Part 1. In each part, people in the study will stay in a research unit for 6 days and 5 nights. Later, they will return to the research unit for 1 check-up. In Part 1, people whose kidneys work normally and people whose kidneys work very poorly (severe renal impairment) can take part. If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work well (mild or moderate renal impairment) can take part. In both parts of the study, people who can take part will be admitted to the research unit. The next day they will take tablets of ASP0367 just once. People will give blood and urine samples at various times during their stay. They will have their vital signs (heart rate and blood pressure) checked regularly. People will also have ECGs to check their heart rhythm. They will be asked if they have any medical problems. After 6 days, provided all the checks have been done and there are no medical problems, people in the study will leave the research unit. People will return to the research unit for 1 check-up. This will be between 9 and 11 days after their last blood sample was taken during their previous stay in the unit. The check-up will include a physical exam, a check of people's vital signs (heart rate and blood pressure), and blood tests. Also, people will have an ECG and be asked if they have had any medical problems. |
| NCT05217901 ↗ | A Study to Evaluate an ASP0367 Solution in Healthy Male Participants | Not yet recruiting | Astellas Pharma Global Development, Inc. | Phase 1 | The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled ASP0367, in particular, the routes of excretion and extent of metabolism of ASP0367 following administration of a single dose of 14C-labeled ASP0367 on day 1 and will also identify the metabolic profile of ASP0367 in plasma, urine, emesis (if applicable) and feces after a single oral dose of 14C-labeled ASP0367. This study will also evaluate safety by having vital signs (heart and blood pressure) and laboratory samples checked regularly. Participants will also have ECGs to check their heart rhythm. The study will be completed with an end-of-study telephone call. The end -of-study call will take place 9 to 11 days after discharge from the clinical unit. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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