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ASP8731 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 59
Awards & highlights

Study Summary

This trial is testing a potential new treatment for sickle cell disease called ASP8731. The study will test different doses of the medication on healthy adults to see how it is processed by and acts upon the body, in order to find a suitable dose and check for potential medical problems from the treatment. The study will be conducted in two parts, with participants visiting the clinic four or five times over the course of several weeks or months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 59
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 59 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events
Part 1: Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Part 1: Number of participants with vital sign abnormalities and/or adverse events (AEs)
+5 more
Secondary outcome measures
Part 1: PK of ASP8731 in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Part 1: PK of ASP8731 in plasma: maximum concentration (Cmax)
Part 1: Pharmacokinetics (PK) of ASP8731 in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
+8 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: ASP8731 6mgExperimental Treatment1 Intervention
Participants receive ASP8731 6mg twice daily for 14 days under fasting conditions.
Group II: Part 1: ASP8731 6mgExperimental Treatment1 Intervention
Participants receive a single dose of ASP8731 6 mg of under fasting conditions.
Group III: Part 1: ASP8731 3mgExperimental Treatment1 Intervention
Participants receive a single dose of ASP8731 3mg under fasting conditions.
Group IV: Part 1: ASP8731 12mgExperimental Treatment1 Intervention
Participants receive a single dose of ASP8731 12 mg under fasting conditions.
Group V: Part 1: ASP8731 PlaceboPlacebo Group1 Intervention
Participants receive a single dose of matching placebo under fasting conditions.
Group VI: Part 2: PlaceboPlacebo Group1 Intervention
Participants receive a multiple matching dose of placebo twice daily for 14 days under fasting conditions.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,026 Total Patients Enrolled
Medical Director Medical SpecialtiesStudy DirectorAstellas Pharma Global Development, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects have been reported in association with ASP8731?

"Due to being only in Phase 1 of clinical trials, the risk associated with ASP8731 is assessed at a low level and therefore scored as a 1."

Answered by AI

Am I eligible to take part in this research?

"Participants must be in the age range of 18 to 55 and remain generally healthy individuals (hs) for eligibility. Altogether, 160 volunteers are needed for this trial."

Answered by AI

Are adults over 20 years of age admissible to this clinical trial?

"In order to qualify for this clinical trial, participants must be between 18 and 55 years of age. Separately, there are 50 trials available for minors and 373 studies open to individuals aged 65 or above."

Answered by AI

Are new participants still being accepted into this research endeavor?

"Clinicaltrials.gov reports that this study is no longer actively recruiting, having been first posted on March 7th 2022 and last edited November 18th 2022. Fortunately, there are 841 other research trials presently open to participants."

Answered by AI

What are the stated aims of this clinical trial?

"The primary objective of the investigation, assessed up to Day 41, is measuring any laboratory value aberrations and/or adverse events associated with ASP8731. Secondary objectives include assessing food effects on AUClast from plasma samples taken after dosing as well as Cmax values also collected during PK tests."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
18 - 65
What site did they apply to?
California Clinical Trials Medical Group
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long does each visit take? How much compensation am I looking at?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I need money and enjoy helping out for the future of mankind.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults
2022. "A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05167526.
~12 spots leftby Apr 2025
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