Debio 1450-111 PK study in healthy volunteers
Research type
Research Study
Full title
A Phase 1, Open-Label, Fixed Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects
IRAS ID
227205
Contact name
Firas Almazedi
Contact email
Sponsor organisation
DebioPharm International S.A
Eudract number
2017-001352-60
Clinicaltrials.gov Identifier
17/EE/0160,
Duration of Study in the UK
0 years, 2 months, 5 days
Research summary
Infections caused by bacteria which are resistant to antibiotics (when antibiotics are unable to fight the bacteria) are one of the main challenges faced by healthcare providers, for example MRSA (sometimes called superbug) which is resistant to a number of widely used antibiotics making it difficult to treat.
Therefore developing an antibiotic that can treat resistant bacteria, like Debio 1450, can be of great importance and benefit to patients.Debio 1450 has been investigated in 336 healthy participants in 10 Phase 1 studies, and 217 patients in 1 Phase 2 study. These studies have shown that the study drug is safe and well-tolerated.
In developing new medicines it is vital that we understand how the Study Drug will interact with other drugs; drug interactions can lead to severe side effects. This is a drug interaction study with another drug called Itraconazole which is used to treat fungal infections Itraconazole is used in this study as it can inhibit one of the liver enzymes that may play a role in breaking down the Study Drug. This study will therefore give us an idea about what will happen to the Study Drug when it is co-administered with drugs that are similar to Itraconazole.Up to 20 participants are planned to take part in this single site research study. The Study will consist of 2 Treatment Periods.. All participants will take part in both Treatment Periods.
In Treatment Period 1 volunteers will receive a single 40 mg-oral-dose of Debio 1450 on Day 1. In Treatment Period 2 they will receive the following treatments:
•Day 1 - 200 mg-oral-dose of Itraconazole twice-daily
•Days 2 to 7 - 200 mg-oral-dose of Itraconazole once-daily.
•Day 5 - 40 mg-oral-dose of Debio 1450 & a single 200 mg oral dose of Itraconazole.In-between Treatment Periods 1 and 2, there will be a washout period of at least 7 days. There will be a post study visit 7-9 days after the final dose of the Study Drug on Day 5. The total duration of study participation for each subject is anticipated to be approximately 7 weeks.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0160
Date of REC Opinion
12 Jun 2017
REC opinion
Further Information Favourable Opinion