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NCT03655301 · ClinicalTrials.gov registry record · Phase 1
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
A Phase 1 study of Healthy Volunteers, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT03655301: Completed Phase 1 study of Healthy Volunteers, sponsored by Bayer.
NCT03655301 is a Phase 1 study of Healthy Volunteers that has completed, run by Bayer. The registered enrollment target is 13 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03655301, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.
Primary Outcome
Maximum observed drug concentration of metformin in plasma after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Copanlisib (Aliqopa, BAY80-6946)
Study Locations (1)
Texas
- Pharmaceutical Product Development (PPD), LLC - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-09-11 |
| Est. Completion | 2019-02-12 |
| Phase | Phase 1 |
What the finished NCT03655301 record still lists
NCT03655301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT03655301 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03655301 about?
NCT03655301 is a clinical study titled "Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics". The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug...
What is the current status of trial NCT03655301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2018-09-11. Estimated completion is 2019-02-12.
What conditions does trial NCT03655301 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03655301?
The interventions under investigation include: Metformin (DRUG), Copanlisib (Aliqopa, BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT03655301?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03655301 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03655301's enrollment target sits among peer trials
13 250th of 283 higher than 33 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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