Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01691924|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : March 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: PBF-509 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
- Number of Adverse Events [ Time Frame: 5-7 days post-dose ]Safety and Tolerability evaluation
- Pharmacokinetic profile analysis [ Time Frame: 0-24 h post dose ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|