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NCT04077879 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect
A Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT04077879: Completed Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
NCT04077879 is a Phase 1 study of Healthy Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 97 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04077879, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.
Primary Outcome
An AE is any untoward medical occurrence in a subject administered an investigational product (IP) and which does not necessarily have to have a causal relationship with this treatment. 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 whether or not considered related to the IP. AE is considered "serious" if the investigator or sponsor view any of the following
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ASP1617
Study Locations (1)
California
- California Clinical Trials Medical Group / Parexel - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2021-06-12 |
| Phase | Phase 1 |
What the finished NCT04077879 record still lists
NCT04077879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04077879 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04077879 about?
NCT04077879 is a clinical study titled "Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect". The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single ora...
What is the current status of trial NCT04077879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2019-09-19. Estimated completion is 2021-06-12.
What conditions does trial NCT04077879 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04077879?
The interventions under investigation include: Placebo (DRUG), ASP1617 (DRUG).
Who is sponsoring clinical trial NCT04077879?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04077879 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04077879's enrollment target sits among peer trials
97 81st of 283 higher than 202 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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