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 processed by and acts upon the body. This study is in healthy men. The main aim of this study is to learn how ASP0367 is processed by and acts upon the bodies of healthy men. To do this, \[14C\] which is a certain chemical (called a tracer, or radionuclide) has been added to ASP0367. \[14C\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \[14C\] will be picked up by a scanner and will be used to follow ASP0367 through the body. \[14C\]ASP0367 will be a liquid. During the study, the men who take part will stay in the clinic for 6 days and 5 nights. Some men may need to stay up to an extra 7 days in the clinic. This will happen if there is a medical reason or if they still have traces of radiation in their blood, urine or feces. On the day before they drink \[14C\]ASP0367, the men will be asked about their medical history, have a medical examination, and have their vital signs checked (blood pressure and pulse). They will also have an ECG to check their heart rhythm. They will give urine, stool and blood samples for laboratory tests. They will also be asked if they have had any medical problems. The men will fast for 10 hours or more before drinking \[14C\]ASP0367 and for 4 hours afterwards. They will only have one drink of \[14C\]ASP0367. They will need to lie still for 4 hours after drinking \[14C\]ASP0367. They will have their vital signs checked and give urine, stool and blood samples for laboratory tests. Then, they will give urine, stool and blood samples every day until they leave the clinic. They will also be asked every day if they have had any medical problems. The day after they drink \[14C\]ASP0367, the men will also have an ECG. On the last clinic day, the men will also have a physical exam, have their vital signs checked and have an ECG. The men can leave the clinic once \[14C\]ASP0367 has left the body and they have no medical problems. About 10 days later, the clinic will call the men to check if there were any further medical problems. No other visits are planned during this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
Oral
Labcorp CRU
Madison, Wisconsin, United States
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in whole blood): Area Under The Concentration Time curve From The Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be recorded from PK whole blood samples collected.
Time frame: Up to 12 days
PK of 14C-labeled ASP0367 (radioactivity in whole blood): Area Under The Concentration-time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast)
AUClast will be recorded from PK whole blood samples collected.
Time frame: Up to 12 days
PK of 14C-labeled ASP0367 (radioactivity in whole blood): Maximum Concentration (Cmax)
Cmax will be recorded from PK whole blood samples collected.
Time frame: Up to 12 days
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUCinf
AUCinf will be recorded from PK plasma samples collected.
Time frame: Up to 12 days
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUClast
AUCinf will be recorded from PK plasma samples collected.
Time frame: Up to 12 days
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): Cmax
AUCinf will be recorded from PK plasma samples collected.
Time frame: Up to 12 days
PK of 14C-labeled ASP0367 (radioactivity ratio of whole blood/plasma concentrations) in blood: Radioactivity Ratio of Area Under The Concentration Time Curve in Blood as Compared to Plasma (AUCblood/AUCplasma)
AUCblood/AUCplasma will be recorded from PK whole blood and plasma samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in urine): amount of administered dose excreted (Ae)
Ae will be recorded from urine samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in urine): percentage of administered dose excreted (Ae percentage)
Ae percentage will be recorded from urine samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in urine): cumulative (over more than 1 sampling interval) amount of administered dose excreted (CumAe)
CumAe will be recorded from urine samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in urine): cumulative (over more than 1 sampling interval) percentage of administered dose excreted (CumAe percentage)
CumAe percentage will be recorded from urine samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in urine): renal clearance (CLR)
CLR will be recorded from urine samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae
Ae will be recorded from feces samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae percentage
Ae percentage will be recorded from feces samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe
CumAe will be recorded from feces samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe percentage
CumAe percentage will be recorded from feces samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): Ae
Ae (if applicable) will be recorded from emesis samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): Ae percentage
Ae percentage (if applicable) will be recorded from emesis samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): CumAe
CumAe (if applicable) will be recorded from emesis samples collected.
Time frame: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): CumAe percentage
CumAe percentage(if applicable) will be recorded from emesis samples collected.
Time frame: Up to 12 days
Number of Participants with Adverse Events (AEs)
An AE will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IP, whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.
Time frame: Up to 23 days
Number of Participants with Laboratory Value Abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 12 days
Number of Participants with Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 5 days
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities and/or AEs
Number of participants with potentially clinically significant 12-Lead ECG values.
Time frame: Up to 5 days
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