A Crossover Study to Assess the Effect of Olpasiran (AMG890) on QT/QTc Intervals in Healthy Subjects
Research type
Research Study
Full title
A Randomized, Placebo- and Positive-controlled, Crossover Study to Assess the Effect of Olpasiran (AMG 890) on QT/QTc Intervals in Healthy Subjects
IRAS ID
1009254
Contact name
Shannon Olson
Contact email
Sponsor organisation
Amgen, Inc.
Clinicaltrials.gov Identifier
Research summary
This is an early phase clinical trial of AMG 890, also called olpasiran, an investigational drug being developed by Amgen, Inc. given as a subcutaneous injection (under the skin).
Olpasiran works by reducing the production of one of the components of a molecule called lipoprotein(a) (abbreviated to Lp(a)) in liver cells. Lp(a) is elevated in people with atherosclerotic cardiovascular disease ( a condition where arteries become thickened or hardened due to a build-up of fatty deposits). By reducing lipoprotein(a), it is hoped olpasiran will help treat people with this condition, decreasing the likelihood of developing related issues like heart attacks and strokes.
Two doses of olpasiran will be used in this trial, both of which have been tested previously in humans. This trial will look at any effect olpasiran might have on the heaii at both doses, specifically any effect it might have on how the heart muscle recharges prior to each heartbeat as measured on the ECG (an electrical tracing of the heart). The trial will also look at how the body handles the drug, the levels of drug in the body, and how safe and well-tolerated the drug is.
The study aims to enroll a total of 32 subjects who will be assessed for eligibility within 28 days prior to checking into the research unit on Day -1. Starting from Day I there will be a total of four visits to clinic, each lasting 6 days. During each visit, subjects will receive a single dose of one of four treatments, the order of which will be randomly determined for each subject: 150mg subcutaneous olpasiran; 675mg subcutaneous olpasiran; a subcutaneous placebo (a dummy medicine that contains no active drug but which looks exactly the same);
or a 400mg tablet of moxifloxacin (an antibiotic that is known to affect recharging of the heart muscle and is routinely used in this type of trial to compare the investigational drug to).
Trial participation will last for approximately 11 weeks.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0250
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion