Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509.
An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical trial where a single oral, dose-escalating, and placebo-controlled design will be implemented.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Randomized, Double Blind, Placebo Controlled "First In-human" Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers|
- Number of Adverse Events [ Time Frame: 5-7 days post-dose ] [ Designated as safety issue: Yes ]Safety and Tolerability evaluation
- Pharmacokinetic profile analysis [ Time Frame: 0-24 h post dose ] [ Designated as safety issue: No ]pre-dose; 10; 20; 30; 40; 50; 60; 75 minutes; 1.5h; 2; 2.5; 3; 3.5; 4; 8; 12; 16; 24 hours postdose administration and after recording vital signs.
|Study Start Date:||October 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo capsules: solid microcrystalline cellulose c.s.p
The initial dose-escalation scheme includes the following eight doses: 10 mg, 20 mg, 40 mg,80 mg, 160 mg, 320 mg, 480 mg and 620 mg. This dose-escalation scheme has been built with the aim to reach the Minimum Intolerated Dose (MID), i.e. when investigator should stop escalating, and consequently the MTD.
|Cim- Sant Pau, HSCSP|
|Barcelona, Catalunya/Barcelona, Spain, 08025|
|Principal Investigator:||Rosa M. Antonijoan, MD||Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau|