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NCT03682484 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
A Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 320
- Enrollment target
- 1
- Study location
NCT03682484: Completed Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
NCT03682484 is a Phase 1 study of Healthy Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 320 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03682484, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 320 participants
- Enrollment target
- 1
- Study location
Study Summary
This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2). The primary purpose of this study is to evaluate the safety and tolerability of single ascending oral doses in Part 1 (SAD Including Evaluation of Food Effect) and multiple ascending oral doses in Part 2 (MAD) of MA-0211 in healthy adult participants. This study will also evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending and multiple ascending oral doses of MA-0211 in healthy adult participants. In addition, this study will evaluate the effect of a single oral dose of MA-0211 on the QT interval using Fridericia's Correction (QTcF); determine the effect of food on the PK of a single oral dose of MA-0211 as well as evaluate the effect of multiple oral doses of MA-0211 on the QTcF.
Primary Outcome
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 a medicinal product.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MA-0211
Study Locations (1)
Maryland
- Parexel - Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2018-03-26 |
| Phase | Phase 1 |
What the finished NCT03682484 record still lists
NCT03682484 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (33% 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.
NCT03682484 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03682484 about?
NCT03682484 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort". This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2). The primary purpose of this study is to evaluate the safety and tolerability of single ascending oral doses in Part 1 (SAD Including E...
What is the current status of trial NCT03682484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2017-06-29. Estimated completion is 2018-03-26.
What conditions does trial NCT03682484 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03682484?
The interventions under investigation include: Placebo (DRUG), MA-0211 (DRUG).
Who is sponsoring clinical trial NCT03682484?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03682484 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03682484's enrollment target sits among peer trials
320 37th of 283 higher than 247 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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