deltatrials
Terminated PHASE1 INTERVENTIONAL 2-arm NCT01379586

A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food on This Profile in Healthy Male and Female Subjects

Sponsor: Ono Pharmaceutical Co. Ltd

Interventions ONO-4053 Placebo
Updated 5 times since 2017 Last updated: Jun 12, 2012 Started: Jun 30, 2011 Primary completion: Jul 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

This PHASE1 trial investigates Healthy Adult Subjects and is currently terminated or withdrawn. Ono Pharmaceutical Co. Ltd leads this study, which shows 5 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 23 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE1

  5. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE1

    First recorded

Jun 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ono Pharmaceutical Co. Ltd
Data source: Ono Pharmaceutical Co. Ltd

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

Study Locations