Status:
COMPLETED
A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to understand how it is ...
Eligibility Criteria
Inclusion
- Participant has a body mass index range of 18.5 to 32.0 kg/m\^2 inclusive and weighs at least 50 kg at screening.
- Male participant with female partner(s) of childbearing potential (including breastfeeding partner\[s\]) must agree to use contraception throughout the treatment period and for 90 days after investigational product (IP) administration.
- Male participant must not donate sperm during the treatment period and for 90 days after IP administration.
- Male participant with pregnant partner(s) must agree to use a condom and spermicide for the duration of the pregnancy throughout the study and for 90 days after IP administration.
- Participant has regular bowel habits (i.e., at least 1 bowel movement per day).
- Participant agrees not to participate in another interventional study while participating in the present study.
Exclusion
- Participant has received any investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening.
- Participant has participated in more than 3 radiolabeled studies within 12 months prior to day -1 (participation in a previous radiolabeled study has to have been at least 4 months prior to day -1 where exposures are known to the investigator, or 6 months prior to day -1 where exposures are not known to the investigator). The cumulative annual radiation exposure from this study and a maximum of 3 previous radiolabeled studies within 12 months prior to day -1 will be within the recommended level of radiation exposure considered to be safe.
- Participant has exposure to significant diagnostic or therapeutic radiation (e.g., serial X ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to day -1.
- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
- Participant has had previous exposure with ASP0367.
- Participant has any of the liver function tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and total bilirubin) ≥ 1.5 x upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
- Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
- Participant has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to IP administration.
- Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
- Participant has any history or evidence of Gilbert's Disease.
- Participant has previously undergone a cholecystectomy.
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
- Participant has any clinically significant abnormality following the physical examination on day -1 and electrocardiogram (ECG) and protocol defined clinical laboratory tests at screening or on day -1.
- Participant has a mean pulse \< 45 or \> 90 bpm; mean systolic blood pressure \> 140 mmHg; mean diastolic blood pressure \> 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of \> 430 msec on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
- Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day), topical dermatological products (including corticosteroid products).
- Participant has smoked, used tobacco containing products and nicotine or nicotine containing products (e.g., electronic vapes) within 6 months prior to screening or the participant tests positive for cotinine at screening or on day -1.
- Participant has a history of consuming \> 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
- Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on day -1.
- Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
- Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
- Participant has a positive serology test for hepatitis A virus antibodies immunoglobulin M, hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
- Participant is an employee of Astellas, the study-related contract research organizations or the clinical unit.
- Participant has consumed grapefruit/Seville orange or grapefruit/Seville orange containing products within 72 hours prior to day -1.
- Participant has received a coronavirus disease 2019 (COVID 19) vaccine within the 2 weeks prior to IP administration or will have a COVID 19 vaccine dose before the end of study telephone call.
- Participant has a positive result for severe acute respiratory syndrome coronavirus 2 test at screening or on day -1.
- Participant has cardiac troponin I (cTnI) \> ULN \[or cardiac troponin T \> ULN if cTnI is not available\] at screening.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05217901
Start Date
January 21 2022
End Date
May 9 2022
Last Update
October 21 2024
Active Locations (1)
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1
Labcorp CRU
Madison, Wisconsin, United States, 53704