Changeflow GovPing Pharma & Drug Safety AZD1043 Safety Study - AstraZeneca/Parexel
Routine Notice Added Final

AZD1043 Safety Study - AstraZeneca/Parexel

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Detected April 6th, 2026
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Summary

The National Library of Medicine updated ClinicalTrials.gov to add a new Phase 1 safety study for AZD1043 sponsored by AstraZeneca and Parexel. The trial is listed as 'not recruiting.' Clinical investigators and pharmaceutical sponsors should ensure their trials are properly registered.

What changed

ClinicalTrials.gov registered a new Phase 1 safety and tolerability study for investigational drug AZD1043. The trial is sponsored by AstraZeneca with Parexel as a site management organization and is currently listed as not recruiting. The registration includes standard trial metadata including study design, eligibility criteria, and anticipated endpoints.

Pharmaceutical sponsors conducting clinical trials subject to FDAAA 801 requirements should verify proper registration status and ensure any changes in recruitment status are updated on ClinicalTrials.gov within 30 days of a change. Clinical investigators should confirm their trial participation status aligns with current registry listings.

What to do next

  1. Verify trial registration compliance if subject to FDAAA 801
  2. Update recruitment status within 30 days of changes per FDAAA requirements
  3. Ensure all required registry fields are complete and accurate

Source document (simplified)

Show glossary

Named provisions

Study Description Eligibility Criteria Study Design Contacts and Locations

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
NLM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07511205

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical Trial Registration Drug Safety Reporting
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Pharmaceuticals Clinical Operations

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