A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men

NCT05217901 | Completed Phase 1 FDA Drug

• 1 other identifier: 0367-CL-1103
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Healthy Volunteers; ASP0367; MA-0211

Outcome Measures

Primary Outcomes (20)

• 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.

  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.

  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.

  Up to 12 days

• Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUCinf

  AUCinf will be recorded from PK plasma samples collected.

  Up to 12 days

• Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): AUClast

  AUCinf will be recorded from PK plasma samples collected.

  Up to 12 days

• Pharmacokinetics (PK) of 14C-labeled ASP0367 (radioactivity in plasma): Cmax

  AUCinf will be recorded from PK plasma samples collected.

  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.

  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.

  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.

  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.

  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.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in urine): renal clearance (CLR)

  CLR will be recorded from urine samples collected.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae

  Ae will be recorded from feces samples collected.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in feces): Ae percentage

  Ae percentage will be recorded from feces samples collected.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe

  CumAe will be recorded from feces samples collected.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in feces): CumAe percentage

  CumAe percentage will be recorded from feces samples collected.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in emesis): Ae

  Ae (if applicable) will be recorded from emesis samples collected.

  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.

  Up to 12 days

• Excretion of 14C-labeled ASP0367 (radioactivity in emesis): CumAe

  CumAe (if applicable) will be recorded from emesis samples collected.

  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.

  Up to 12 days

Secondary Outcomes (4)

• Number of Participants with Adverse Events (AEs)

  Up to 23 days

• Number of Participants with Laboratory Value Abnormalities and/or AEs

  Up to 12 days

• Number of Participants with Vital Sign Abnormalities and/or AEs

  Up to 5 days

• Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities and/or AEs

  Up to 5 days

Study Arms (1)

14C-labeled ASP0367

EXPERIMENTAL

Participants will receive a single oral dose of \[14C\]ASP0367 solution under fasting conditions on day 1.

Drug: 14C-labeled ASP0367

Interventions

14C-labeled ASP0367 DRUG

Oral

Also known as: MA-0211, bocidelpar

14C-labeled ASP0367

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Labcorp CRU

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Associate Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: January 21, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 9, 2022
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)