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

NCT02907294 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-09-20

No results posted yet for this study

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

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

Sponsors & Collaborators

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

    collaborator OTHER

  • Palobiofarma SL

    lead INDUSTRY

Principal Investigators

  • Joan Martinez, MD · CIM-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
2016-03-31
Primary Completion
2016-04-30
Completion
2016-05-31

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 NCT02907294 on ClinicalTrials.gov