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Completed

NCT Number: NCT03655301

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, 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Product Development (PPD), LLC

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copanlisib (ALIQOPA, BAY80-6946)

Drug

The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.

In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.

metformin

Drug

Single dose of 1000 mg is administered orally.

Primary outcomes

  1. Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax)

    Time frame: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8

    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.

  2. Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours of Metformin After Single Dose Administration (AUC[0-24])

    Time frame: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8

    Area under the concentration versus time curve from zero to 24 hours of metformin after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.

  3. Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Metformin After Single Dose Administration (AUC)

    Time frame: Pre-dose and extrapolated up to infinity after drug administration on Day 1 and Day 8

    Area under the concentration verus time curve from zero to infinity of metformin after single dose without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: From start of study medication until 30 days after end of treatment with study medication.

    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the start of study drug administration up to 30 days after last administration of the study medication.

  2. Number of Participants With Treatment-Emergent Adverse Events by Severity

    Time frame: From start of study medication until 30 days after end of treatment with study medication.

    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the start of study drug administration up to 30 days after last administration of the study medication. TEAEs per severity were reported.

  3. Plasma Lactate Levels

    Time frame: Up to 24 hours after study drug administration on Day 1 and Day 8

    Lactate levels were analyzed in plasma samples collected during metformin alone or in combination with copanlisib. Plasma lactate levels were summarized by treatment conditions (Day 1 and Day 8).

  4. Maximum Change From Baseline in Plasma Lactate Levels

    Time frame: From pre-dose up to 24 hours after study drug administration on Day 1 and Day 8

    Lactate levels were analyzed in plasma samples collected during metformin alone or in combination with copanlisib. Maximum change from baseline on Day 1 and Day 8 was summarized.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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