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NCT04536792 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT04536792 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 122 participants.
The verdict
NCT04536792, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration of single ascending doses (SAD) and multiple ascending doses (MAD) of AG-946 over 14 or up to 28 days of dosing, and to identify a range of doses that are safe and pharmacologically active in participants with sickle cell disease. The SAD and MAD parts of the study will be randomized and double-blinded, and will assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of AG-946 as well as the effect of food (SAD only) on the pharmacokinetics (PK) of AG-946. The sickle cell disease (SCD) part of the study will be non-randomized and open-label, and is designed to identify 1 or more safe and tolerable dose(s) of AG-946 with potential activity in the treatment of participants with sickle cell disease (SCD).
Interventions
- DRUG AG-946
- DRUG AG-946 Matched Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2023-12-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04536792
The ClinicalTrials.gov registry entry for NCT04536792 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AG-946 is the first listed.
NCT04536792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04536792 about?
NCT04536792 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease". The purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration of single ascending doses (SAD) and multiple ascending doses (MAD) of AG-946 over 14 or up to 28 days of dosing, and to identify a range of doses that are safe and pharmacologi...
What is the current status of trial NCT04536792?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2020-07-10. Estimated completion is 2023-12-19.
What interventions are being tested in trial NCT04536792?
The interventions under investigation include: AG-946 (DRUG), AG-946 Matched Placebo (DRUG).
Who is sponsoring clinical trial NCT04536792?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
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