NCT02208973

Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 After Multiple Oral Doses"

Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 "After Multiple Oral Doses" in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg and 60mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	PBF-680	5, 10, 20, 40 and 60 mg of PBF-680
DRUG	Placebo	placebo for the dose of 5, 10, 20 and 40 mg of PBF-680

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-08-05
• Last updated: 2016-03-08

Locations

2 sites across 1 country: Spain