"First-in-human" Study To Assess the Safety and Tolerability of PBF-677 in Healthy Volunteers
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
The proposed trial a "Randomized, Double Blind, Placebo Controlled "first in-human" Study to
Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-677 in Male Healthy
Volunteers" (Protocol Code No:CUNFI-1509 EudraCT No:2015-003546-57) will be a single-centre,
randomized, double-blind, dose escalation study without therapeutic benefit, in which PBF-677
will be administered as single, oral, ascending-dose to volunteers.
Up to four different rising doses (100 mg, 200 mg, 400 mg and 600 mg) will be tested in
groups of 8 participants; in each dose level participants will be randomized to active drug
or placebo in a 6:2 fashion. As this will be the first time that PBF-677 in going to be
administered to humans, as a safety measure a stepwise drug administration will be performed
in each cohort. The volunteers of each cohort will be divided in 3 blocks/subgroups:
Initially, one volunteer will receive active drug (subgroup 1). After 48h of safety and
tolerability assessment, a second subgroup of 3 volunteers will receive 2 active drug and 1
placebo and after further 48h of safety and tolerability assessments a third subgroup of 4
volunteers will receive 3 active drug and 1 placebo. After evaluation of safety, parameters
of corresponding dose level the process will replicate one week afterwards in the following
dosages.
The principal variable safety and tolerability of PBF-677 will be evaluated with physical
records (Electrocardiogram (ECG), vital signs, blood chemistry and haematology, conducted
before, during and after study course). Assessment of the pharmacokinetic profile (Maximum
plasma concentration of the drug (peak) after single dose (Cmax),Time necessary to reach Cmax
(tmax), Area under the time-concentration curve to "zero" to time "t" (AUC0t), and
Elimination half-life (t1/2) of PBF-677 will be included as secondary variable.