deltatrials
Terminated PHASE1 INTERVENTIONAL 6-arm NCT02432664

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ODM-108: in Healthy Male Volunteers (FIMTRIP)

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single and Multiple Escalating Doses of ODM-108: A Single Centre Study in Healthy Male Volunteers

Sponsor: Orion Corporation, Orion Pharma

Conditions Healthy
Interventions Midazolam ODM-108 Part I ODM-108 Part III ODM-108-Part II Placebo Part I Placebo Part II
Updated 10 times since 2017 Last updated: Jun 30, 2017 Started: Apr 14, 2015 Primary completion: Apr 22, 2016 Completion: Apr 22, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated after the second cohort had completed Part II due complex PK results. There were no safety concerns.

Other terminated trials from Orion Corporation, Orion Pharma

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Other Healthy trials with similar outcome

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This PHASE1 trial investigates Healthy and is currently terminated or withdrawn. Orion Corporation, Orion Pharma leads this study, which shows 10 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 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 · 23 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. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE1

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE1

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE1

  4. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE1

  5. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE1

    First recorded

Apr 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Orion Corporation, Orion Pharma
  • PRA Health Sciences
Data source: Orion Corporation, Orion Pharma

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

Study Locations