Trials / Completed
CompletedNCT03172884
Study of Copanlisib in Hepatic or Renal Impairment
An Open-label Non-randomized, Phase 1 Single Dose Study to Evaluate the Pharmacokinetics and Safety of Copanlisib in Subjects With Impaired Hepatic or Renal Function in Comparison to Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Copanlisib (ALIQOPA, BAY80-6946) | 12mg single dose, intravenous on Day 0 |
Timeline
- Start date
- 2017-06-14
- Primary completion
- 2020-03-13
- Completion
- 2020-05-15
- First posted
- 2017-06-01
- Last updated
- 2021-04-28
- Results posted
- 2021-04-01
Locations
2 sites across 2 countries: Germany, Romania
Source: ClinicalTrials.gov record NCT03172884. Inclusion in this directory is not an endorsement.