Healthy Clinical Trial
Official title:
A Single Ascending Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Orally Administered BDM-2 in Healthy Male Subjects
This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated.
The Sponsor HIVIH is developing a new antiretroviral medicine, BDM-2, for the potential
treatment of Human Immunodeficiency Virus (HIV). The study will investigate 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 will be 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. 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.
To investigate the effect of food, it is planned that in Period 7 the medicine will be
administered in the fed state. On the 7th study period one of the doses administered in a
previous period will be administered under fed conditions (with food). Each volunteer will
receive 3 or 4 single doses of test medicine or placebo.
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