deltatrials
Terminated PHASE1 INTERVENTIONAL 11-arm NCT04452006

A Study in Healthy Subjects to Investigate the Safety and Tolerability of ACT- 541478 as Well as What ACT-541478 Does to the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-541478

Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects

Sponsor: Idorsia Pharmaceuticals Ltd.

Conditions Healthy
Updated 7 times since 2020 Last updated: Jul 6, 2021 Started: Jul 20, 2020 Primary completion: Apr 20, 2021 Completion: Apr 20, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Based on interim analysis, the Sponsor decided to terminate the study prematurely.

This PHASE1 trial investigates Healthy and is currently terminated or withdrawn. Idorsia Pharmaceuticals Ltd. leads this study, which shows 7 recorded versions since 2020 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshotNot Yet Recruiting~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshotNot Yet Recruiting~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Sep 2021 — Jul 2024 [monthly]

    Terminated PHASE1

    Status: RecruitingTerminated

  4. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  5. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

Show 2 earlier versions
  1. Aug 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE1

  2. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

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