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

NCT02208973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-08

No results posted yet for this study

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

Interventions

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

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

  • Joan Martínez Colomer, MD · CIM Sant Pau - IIB 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
2014-05-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02208973 on ClinicalTrials.gov