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Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) "After Multiple Oral Doses" in Healthy Volunteers

NCT02111330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-03-08

No results posted yet for this study

Summary

Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240 mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

Conditions

  • Parkinson Disease

Interventions

DRUG

PBF-509

DRUG

Placebo

Sponsors & Collaborators

  • Palo Biofarma, S.L

    collaborator INDUSTRY

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Juan Martínez Colomer, MD · CIM Sant Pau - I.I.B. Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02111330 on ClinicalTrials.gov