Safety and blood levels of single & repeated doses of MK-1972; v1
Research type
Research Study
Full title
A study to evaluate the safety and pharmacokinetics of single and multiple doses of MK-1972
IRAS ID
58002
Contact name
Steve Warrington
Sponsor organisation
Merck & Co. Inc.
Eudract number
2010-020491-32
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The study medicine is an experimental treatment for HIV-1 infection.We hope that it will work against some types of HIV-1 viruses that can-t be treated at prisent. Volunteers have already taken very low doses of the study medicine, but this is the first study of doses that could be used to treat HIV patientsThe study is in 2 parts.In Part 1, We'll test single doses of the study medicine, and in Part 2, We'll test repeated doses for 7 days.In both parts, We'll start with a low dose, and increase the dose as the study progresses.Some Participants will take dummy medicine according to a code kept inosealed envelopes.We aim to find out the side effects and blood levels of the study medicine.We'll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.In Part 1 of the study, We'll also test whether food affects blood levels of the study medicine.There will be up to 48 healthy men in the study, aged 18-45 years.Participants in Part 1 will take up to 12 weeks to finish the study.They will stay on the ward for 10 nights in total, and make 17 outpatient visits.Participants in Part 2 will take up to 7 weeks to finish the study.They will stay on the ward for 8 nights, and make 5 outpatient visits.A pharmaceutical company is funding the study, which will take place at 1 centre in London.We'll recruit healthy Participants by: advertising in newspapers and on websites; by word of mouth; and from our volunteer database.
REC name
Scotland A REC
REC reference
10/IEC02/19
Date of REC Opinion
21 Jul 2010
REC opinion
Further Information Favourable Opinion