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.

Start Date21 Jan 2022

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT05117294 / CompletedPhase 1

A Phase 1 Open Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP0367 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function

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.

Start Date21 Dec 2021

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT04942964 / CompletedPhase 1

A Phase 1 Open-label Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP0367 Compared to Participants With Normal Hepatic Function

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.

Start Date13 Sep 2021

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

100 Clinical Results associated with Bocidelpar

100 Translational Medicine associated with Bocidelpar

100 Patents (Medical) associated with Bocidelpar

Literatures (Medical) associated with Bocidelpar

01 Jan 2022·Muscle & nerve

Single‐ and multiple‐dose safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of ASP0367, or bocidelpar sulfate, a novel modulator of peroxisome proliferator‐activated receptor delta in healthy adults: Results from a phase 1 study

Article

Author: Goldwater, Ronald D. ; Yamada, Akihiro ; Marek, Gerard J. ; Uz, Tolga ; Smulders, Ronald A. ; Tauscher‐Wisniewski, Sitra ; Wojtkowski, Tomasz ; Ito, Mototsugu ; Koibuchi, Akira

Abstract:

Introduction/Aims:

ASP0367, or bocidelpar sulfate, is an orally administered small molecule that potently and selectively modulates peroxisome proliferator–activated receptor δ (PPARδ) to address mitochondrial dysfunction occurring in diseases including primary mitochondrial myopathy and Duchenne muscular dystrophy. The objectives of this first‐in‐human trial were to evaluate the safety/tolerability, pharmacokinetics, and pharmacodynamics of ASP0367 in healthy participants.

Methods:

In this double‐blind phase 1 study, adult participants were randomized to single or multiple ascending oral doses of ASP0367 or placebo. The study duration was 1 and 14 days, respectively. Pharmacokinetic parameters under fed conditions were also evaluated.

Results:

A total of 64 (single‐dose cohort) and 37 (multiple‐dose cohort) participants were included in the study. After single doses of 1 to 120 mg, ASP0367 was rapidly absorbed, with median time to maximum plasma concentration (tmax) of 1.50 to 2.24 hours under fasting conditions; ASP0367 concentrations declined in a multiphasic manner after reaching maximum plasma concentration. Under fed conditions, tmax was delayed 1.7 hours. After multiple once‐daily doses, mean half‐life of ASP0367 10 to 75 mg ranged from 14.1 to 17.5 hours; steady state was reached after 4 days. Negligible accumulation was observed after repeated dosing. No participants receiving ASP0367 discontinued treatment, and all treatment‐emergent adverse events were mild to moderate in severity; none were considered drug‐related. No clinically significant changes were observed on laboratory or electrocardiographic evaluation. Treatment‐ and dose‐dependent upregulation of six PPARδ target genes was observed with single and multiple doses of ASP0367.

Discussion:

ASP0367, or bocidelpar sulfate, was well tolerated; rapid absorption, roughly dose‐proportional bioavailability, and effects on PPARδ target genes were demonstrated in healthy adult participants.

News (Medical) associated with Bocidelpar

25 Apr 2024

·firstwordpharma.com

Astellas reports a revenue win for 2023, cuts two early programmes

Astellas saw an uptick in revenues for fiscal year 2023 that beat its own projections, the Japanese firm announced Thursday. Its earnings report also revealed that a pair of early-stage programmes have been discontinued.The pipeline trim comes just weeks after the company booked an impairment charge of JPY 70 billion ($453 million) for the first quarter of 2024 due to sluggish sales and clinical setbacks for a trio of therapies. The axed programmes are ASP2074, a bispecific antibody targeting TSPAN8 and CD3, and PPAR-delta modulator ASP0367. The former, an internally developed candidate, was in Phase I testing for metastatic or locally advanced solid tumours. The second compound was acquired via Astellas’ 2018 purchase of Mitobridge. ASP0367 was in a Phase I trial for Duchenne muscular dystrophy and a Phase II study for primary mitochondrial myopathies, an indication for which it held fast-track designation from the FDA.Xtandi sales increaseOn the more positive side, Astellas reported 2023 revenues of JPY 1.6 trillion, up 5.6% from the year prior and ahead of its internal forecast of JPY 1.56 trillion.The beat was driven by increased sales of prostate cancer drug Xtandi (enzalutamide), which brought in more than JPY 750 billion for the year, representing a 14% increase over 2022 sales. The figure also surpassed projections of JPY 719.8 billion. Earlier this week, Xtandi scored a label expansion in the EU for non-metastatic hormone-sensitive prostate cancer.Astellas expects revenue for fiscal year 2024 to reach JPY 1.65 trillion.

Phase 1Fast TrackAcquisitionIPOPhase 2

100 Deals associated with Bocidelpar

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mitochondrial Myopathies	Phase 3	US	Astellas Pharma, Inc.	23 Apr 2021
Liver Injury	Phase 1	US	Astellas Pharma Global Development, Inc.	13 Sep 2021
Hypoxia	Phase 1	US	Astellas Pharma, Inc.	19 May 2021
Muscular Dystrophy, Duchenne	Phase 1	US	Astellas Pharma, Inc.	-

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