Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

Bayer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Metformin; Drug: Copanlisib (Aliqopa, BAY80-6946)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03655301

19951

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects - as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
• Aged 18 to 45 years at the first screening visit
• Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight ≥ 50 kg
• Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease
• Adequate end organ and bone marrow function

Exclusion criteria

• Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Relevant respiratory insufficiency / disorder
• Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
• Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Copanlisib (Aliqopa, BAY80-6946)

Experimental group

Description:

All subjects will receive a single dose of metformin 1000 mg on Days 1 and 8 in a fasting state. Subjects will also receive a single i.v. dose of 60 mg copanlisib on Day 8 as part of the combination with metformin.

Treatment:

Drug: Copanlisib (Aliqopa, BAY80-6946)

Drug: Metformin