Most Read Articles
Stephen Padilla, 31 Jan 2020
The combination of ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (DMR) delivers faster responses, better response rates and greater satisfaction compared with monotherapy in patients with severe rosacea, a recent study has shown.
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. 
Stephen Padilla, 08 Apr 2020
An antiparasitic drug approved by the Food and Drug Administration (FDA) has been found to be effective in stopping the growth of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a laboratory experiment, according to a collaborative study.

Gadopiclenol does not prolong QTc interval in healthy individuals

21 Nov 2020

A new gadolinium-based contrast agent, gadopiclenol, at clinical and supraclinical doses does not result in prolonged QT interval and has an acceptable safety profile among healthy volunteers, a recent study has found.

“The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation,” the investigators said. “However, the amplitude of this effects is unlikely to be associated with proarrhythmia.”

This single-centre, randomized, double-blind, placebo- and positive-controlled, four-way crossover study included 48 healthy male and female individuals who received single intravenous (IV) administration of gadopiclenol at a clinical dose of 0.1 mmol kg-1 (standard for current gadolinium-based contrast agents), a supraclinical dose of 0.3 mmol kg-1, placebo, and a single oral dose of moxifloxacin 400 mg.

The biggest time‐matched, placebo‐corrected, mean change from‐baseline in QTcF (ΔΔQTcF) was seen 3 hours after administration of 0.1 mmol kg−1 gadopiclenol (2.39 ms, 90 percent confidence interval [CI], 0.35–4.43) and 5 minutes after administration of 0.3 mmol kg−1 (4.81 ms, 90 percent CI, 2.84–6.78).

The upper limit of the 90 percent CI was under the threshold of 10 ms, which showed no substantial effect of gadopiclenol on QTc interval. The lower limit of the 90 percent CI of ΔΔQTcF from 1.5–4 hours postdose moxifloxacin exceeded 5 ms, indicating assay sensitivity.

A positive slope was observed, but the concentration–response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg-1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90 percent CI not exceeding 10 ms.

There were no serious or adverse events (AEs) or treatment discontinuations due to AEs reported, according to the investigators.

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Pharmacist - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Stephen Padilla, 31 Jan 2020
The combination of ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (DMR) delivers faster responses, better response rates and greater satisfaction compared with monotherapy in patients with severe rosacea, a recent study has shown.
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. 
Stephen Padilla, 08 Apr 2020
An antiparasitic drug approved by the Food and Drug Administration (FDA) has been found to be effective in stopping the growth of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a laboratory experiment, according to a collaborative study.