Healthy VolunteersPhase 1NCT05217901
A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men
A Phase 1 study testing 14C-labeled ASP0367 in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial 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 processed by and acts upon the body. This study is in healthy men. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 14C-labeled ASP0367
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 9 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]ASP0367 Solution in Healthy Male Participants
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- 14C-labeled ASP0367
- Keywords
- Pharmacokinetics, Healthy Volunteers, ASP0367, MA-0211
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-labeled ASP0367Drug
Also called MA-0211, bocidelpar
Oral
| Study group | Role | What they receive |
|---|---|---|
| 14C-labeled ASP0367 | Experimental | Participants will receive a single oral dose of [14C]ASP0367 solution under fasting conditions on day 1. Receives: Drug: 14C-labeled ASP0367 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 days
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUCinf
AUCinf will be recorded from PK plasma samples collected.
Measured: Up to 12 days
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUClast
AUCinf will be recorded from PK plasma samples collected.
Measured: Up to 12 days
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): Cmax
AUCinf will be recorded from PK plasma samples collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in urine): renal clearance (CLR)
CLR will be recorded from urine samples collected.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae
Ae will be recorded from feces samples collected.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae percentage
Ae percentage will be recorded from feces samples collected.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe
CumAe will be recorded from feces samples collected.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe percentage
CumAe percentage will be recorded from feces samples collected.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): Ae
Ae (if applicable) will be recorded from emesis samples collected.
Measured: 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.
Measured: Up to 12 days
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): CumAe
CumAe (if applicable) will be recorded from emesis samples collected.
Measured: 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.
Measured: Up to 12 days
Secondary outcomes (4)
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.
Measured: Up to 23 days
Number of Participants with Laboratory Value Abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 12 days
Number of Participants with Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: 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.
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start21 Jan 2022
- Primary completion30 Apr 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217901
- Sponsor's protocol ID
- 0367-CL-1103
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]ASP0367 Solution in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05217901
- Acronym / sponsor ID
- 0367-CL-1103
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Healthy Volunteers, ASP0367, MA-0211
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-labeled ASP0367 | Experimental | Drug: 14C-labeled ASP0367Participants will receive a single oral dose of [14C]ASP0367 solution under fasting conditions on day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-labeled ASP0367Also: MA-0211, bocidelparOral | Drug | 14C-labeled ASP0367 |
Primary outcome
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)
Time frame: Up to 12 days
AUCinf will be recorded from PK whole blood samples collected.
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)
Time frame: Up to 12 days
AUClast will be recorded from PK whole blood samples collected.
PK of 14C-labeled ASP0367 (radioactivity in whole blood): Maximum Concentration (Cmax)
Time frame: Up to 12 days
Cmax will be recorded from PK whole blood samples collected.
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUCinf
Time frame: Up to 12 days
AUCinf will be recorded from PK plasma samples collected.
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUClast
Time frame: Up to 12 days
AUCinf will be recorded from PK plasma samples collected.
Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): Cmax
Time frame: Up to 12 days
AUCinf will be recorded from PK plasma samples collected.
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)
Time frame: Up to 12 days
AUCblood/AUCplasma will be recorded from PK whole blood and plasma samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in urine): amount of administered dose excreted (Ae)
Time frame: Up to 12 days
Ae will be recorded from urine samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in urine): percentage of administered dose excreted (Ae percentage)
Time frame: Up to 12 days
Ae percentage will be recorded from urine samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in urine): cumulative (over more than 1 sampling interval) amount of administered dose excreted (CumAe)
Time frame: Up to 12 days
CumAe will be recorded from urine samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in urine): cumulative (over more than 1 sampling interval) percentage of administered dose excreted (CumAe percentage)
Time frame: Up to 12 days
CumAe percentage will be recorded from urine samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in urine): renal clearance (CLR)
Time frame: Up to 12 days
CLR will be recorded from urine samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae
Time frame: Up to 12 days
Ae will be recorded from feces samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae percentage
Time frame: Up to 12 days
Ae percentage will be recorded from feces samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe
Time frame: Up to 12 days
CumAe will be recorded from feces samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe percentage
Time frame: Up to 12 days
CumAe percentage will be recorded from feces samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): Ae
Time frame: Up to 12 days
Ae (if applicable) will be recorded from emesis samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): Ae percentage
Time frame: Up to 12 days
Ae percentage (if applicable) will be recorded from emesis samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): CumAe
Time frame: Up to 12 days
CumAe (if applicable) will be recorded from emesis samples collected.
Excretion of 14C-labeled ASP0367 (radioactivity in emesis): CumAe percentage
Time frame: Up to 12 days
CumAe percentage(if applicable) will be recorded from emesis samples collected.
4 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to 23 days
Number of Participants with Laboratory Value Abnormalities and/or AEs
Time frame: Up to 12 days
Number of Participants with Vital Sign Abnormalities and/or AEs
Time frame: Up to 5 days
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities and/or AEs
Time frame: Up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associate Medical Director study director
Astellas Pharma Global Development, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-labeled ASP0367 in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 12 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.