Safety, Tolerability and PK of BDM-2 in Healthy Subjects (QCL118184)
Research type
Research Study
Full title
A single ascending dose trial investigating the safety, tolerability and pharmacokinetics of orally administered BDM-2 in healthy male subjects.
IRAS ID
240028
Contact name
Ibrahima Guillard
Contact email
Sponsor organisation
HIVIH
Eudract number
2017-004329-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
The Sponsor HIVIH is developing a new antiretroviral medicine, BDM-2, for the potential treatment of Human Immunodeficiency Virus (HIV). The HIV virus damages cells in the immune system and weakens the ability to fight everyday infections and disease. AIDS (acquired immune deficiency syndrome) is the name used to describe a number of potentially life-threatening infections and illnesses that happen when the immune system has been severely damaged by the HIV virus.
The study will try to identify the safety, tolerability and pharmacokinetics (PK) (how well the medicine is taken up by the body) of single doses of the test medicine given by mouth, in healthy male volunteers. The effect of food on the PK of the test medicine will also be assessed.
This is the first time the medicine has been dosed in humans.
Over 6 study periods, ascending (increasing) doses of the test medicine or placebo (dummy drug) will be given to 16 healthy male volunteers in the fasted state, alternately dosed to two groups each made up of 8 volunteers. To investigate the effect of food, it is planned that in Period 7 the medicine will be administered in the fed state, however administration with food may take place in earlier periods, depending on emerging data. On the 7th study period one of the doses administered in a previous period will be administered under fed conditions (with food). Therefore, each volunteer will receive 3 or 4 single doses of test medicine or placebo. After each dose volunteers will remain in the clinical unit for 48 hours for blood samples to be taken and safety assessments to be performed.
REC name
HSC REC A
REC reference
18/NI/0054
Date of REC Opinion
6 Apr 2018
REC opinion
Favourable Opinion