deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT03655301

Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers

Sponsor: Bayer

Updated 12 times since 2018 Last updated: Jan 14, 2020 Started: Sep 11, 2018 Primary completion: Nov 12, 2018 Completion: Feb 12, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03655301, this PHASE1 trial focuses on Healthy Volunteers and remains completed. Sponsored by Bayer, it has been updated 12 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshotNot Yet Recruiting~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshotRecruiting~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshotActive Not Recruiting~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshotActive Not Recruiting~Mar 2019 – ~Jan 2020 · 10 months · monthly snapshotCompleted~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshotCompleted~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

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

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE1

Show 7 earlier versions
  1. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE1

  2. Jan 2020 — Feb 2020 [monthly]

    Completed PHASE1

  3. Mar 2019 — Jan 2020 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  4. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1

  5. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  6. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  7. Sep 2018 — Nov 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bayer
Data source: Bayer

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

Study Locations