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
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
Change History
12 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jan 2023 — Jul 2024 [monthly]
Completed PHASE1
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE1
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Jan 2021 — Dec 2022 [monthly]
Completed PHASE1
▶ Show 7 earlier versions
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Feb 2020 — Jan 2021 [monthly]
Completed PHASE1
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Jan 2020 — Feb 2020 [monthly]
Completed PHASE1
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Mar 2019 — Jan 2020 [monthly]
Completed PHASE1
Status: Active Not Recruiting → Completed
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Feb 2019 — Mar 2019 [monthly]
Active Not Recruiting PHASE1
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Jan 2019 — Feb 2019 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
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Nov 2018 — Jan 2019 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
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Sep 2018 — Nov 2018 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Bayer
For direct contact, visit the study record on ClinicalTrials.gov .