NCT02907294

Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 "After Multiple Oral Doses" in Healthy Volunteers

Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 (160 mg and 320 mg) "After Multiple Oral Doses" in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Palobiofarma SL · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	PBF-999 / 160 mg	2 capsule 80 mg x 8 days
DRUG	PBF-999 / 320 mg	4 capsule 80 mg x 8 days
DRUG	Placebo	2 capsules of placebo x 8 days 4 capsules of placebo x 8 days

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2016-09-20
• Last updated: 2016-09-20

Locations

1 site across 1 country: Spain