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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691924
|Palobiofarma S.L. (molecule owner)|
|Mataró, Barcelona, Spain, 08302|
|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|