Effect of Intravenous APD421 on Cardiac Conduction in Healthy Subjects
Research type
Research Study
Full title
A Randomised, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous APD421 on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects.
IRAS ID
137159
Contact name
Taubel Jorg
Contact email
Sponsor organisation
Acacia Pharma
Eudract number
2013-002669-20
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
We are conducting a clinical research study with a medicine known as APD421 which is being developed for prevention and treatment of nausea and vomiting e.g. following surgery or chemotherapy. APD421 is as an intravenous form of a marketed oral drug (amisulpride) which has been used for years for treatment of schizophrenic disorders. In this study we will assess the effect of oral APD421 on the ECG (electrocardiogram) parameter known as QTc interval. The QTc interval is one of the indicators of the time taken in milliseconds for electrical impulses to pass through the heart. A prolonged QTc interval can lead to irregular heartbeats (known as arrhythmia). Certain types of drugs including antibiotics such as moxifloxacin are known to modestly prolong the QTc interval and hence the effect of ADP421 will be compared to moxifloxacin.
We will also assess the pharmacokinetics (PK - levels of drug in the blood) and safety. Volunteers will receive 3 single intravenous dose of APD421, moxifloxacin and placebo (dummy drug). Volunteers must attend our clinical unit for approximately 7 visits including 1 or 2 screening visits, 5 residential periods and 1 follow-up outpatient visit. Each residential stay in our unit is over 4 days (3 nights) during which time, volunteers will be administered the study drugs on Day 1 of each period; followed by a washout period of at least 7 days between each dosing.
Volunteers will be involved in the study for up to 80 days including the time when we determine who is suitable for taking part in the study, conduct of the study and the follow-up, 7-14 days after discharge from the unit. The main procedures will include standard laboratory safety tests (haematology, biochemistry, and urinalysis), vital signs (blood pressure and pulse), physical examinations, 12-lead ECG, PK blood samples and monitoring of side effects
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0496
Date of REC Opinion
14 Oct 2013
REC opinion
Further Information Favourable Opinion