deltatrials
Terminated PHASE1 INTERVENTIONAL 5-arm NCT02905253

A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

A Three-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers

Sponsor: Idorsia Pharmaceuticals Ltd.

Interventions AC-084 Placebo
Updated 10 times since 2017 Last updated: Jul 6, 2018 Started: Sep 12, 2016 Primary completion: Dec 10, 2017 Completion: Dec 10, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study has been terminated due to difficulties in recruiting subjects into Part C. No safety concerns contributed to the termination of the study

Listed as NCT02905253, this PHASE1 trial focuses on Healthy Subjects and remains terminated or withdrawn. Sponsored by Idorsia Pharmaceuticals Ltd., it has been updated 10 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Apr 2017 · 3 months · monthly snapshotRecruiting~Apr 2017 – ~May 2018 · 13 months · monthly snapshotRecruiting~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshotTerminated~Aug 2018 – ~Nov 2020 · 27 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE1

Show 5 earlier versions
  1. Aug 2018 — Nov 2020 [monthly]

    Terminated PHASE1

  2. Jun 2018 — Aug 2018 [monthly]

    Terminated PHASE1

  3. May 2018 — Jun 2018 [monthly]

    Terminated PHASE1

    Status: RecruitingTerminated

  4. Apr 2017 — May 2018 [monthly]

    Recruiting PHASE1

  5. Jan 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

    First recorded

Sep 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Idorsia Pharmaceuticals Ltd.
Data source: Idorsia Pharmaceuticals Ltd.

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

Study Locations