deltatrials
Completed PHASE1 INTERVENTIONAL 5-arm NCT00485667

Phase 1 Thorough QT Study in Young Healthy Volunteers (TQT)

Evaluation of the Effects of Therapeutic and Supra-therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QT/QTc Interval in Young Healthy Volunteers. A Prospective, Randomized, Placebo- and Positive-controlled, Double Blind, Single-centre, Crossover Phase 1 Study.

Sponsor: Pacira Pharmaceuticals, Inc

Updated 7 times since 2017 Last updated: Feb 11, 2021 Started: Jun 30, 2007 Primary completion: Aug 31, 2007 Completion: Aug 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Postoperative Pain and is currently completed. Pacira Pharmaceuticals, Inc leads this study, which shows 7 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotCompleted~Mar 2021 – ~Jul 2024 · 40 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Mar 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Mar 2021 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Jun 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pacira Pharmaceuticals, Inc
  • Richmond Pharmacology Limited
Data source: Pacira Pharmaceuticals, Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations