"First-in-human" Study To Assess the Safety and Tolerability of PBF-680 in Male Healthy Volunteers
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
This is a phase I, single-center, randomized, double-blind, dose escalation study without
therapeutic benefit, in which PBF-680 will be administered as single oral ascending dose to
young male healthy volunteers. Up to four different rising doses will be tested in groups of
8 participants. Thus, four groups will participate but each one participating only once. For
each dose level / group the participants will be randomized to active or placebo with 2
participants being randomly assigned to placebo and 6 to the active drug. First, 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; after
48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will
receive 3 active drug and 1 placebo. After evaluation of safety parameters of dose level the
process will replicate one week afterwards in the following dosages.
The aims of this study are:
Primary:
- To assess the safety and tolerability of single escalating oral doses of PBF-680 in young
male healthy subjects leading to the determination of the maximum tolerated dose (MTD).
Secondary:
- To assess the pharmacokinetics of PBF-680 after single rising oral doses in healthy
young male subjects.
- To asses the preliminary pharmacodynamic effects.
- To evaluate the adenosine A1 receptor antagonism in blood samples of healthy volunteer
caused by the PBF-680 administration
Phase:
Phase 1
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau