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Tolerability and Steady-state Pharmacokinetics of BIA 6-512

NCT03093389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-28

No results posted yet for this study

Summary

To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers.

Conditions

  • Parkinson Disease

Interventions

DRUG

BIA 6-512

The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 100 mg and 150 mg. Products were administered orally, with approximately 240 mL of water in case of Doses 1 and 13, and at least 150 mL of water in case of Doses 2 to 12. First dose (Dose 1) and last dose (Dose 13) were administered in fasting of at least 8 hours and subject remained fasted until to 2.5 h post-dose. Meals were not served within 1 hour prior and 1 hour after investigational product administration in Doses 2 to 12

DRUG

Placebo

Matching placebo capsules

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2005-05-11
Primary Completion
2005-07-29
Completion
2005-07-29

Countries

  • Portugal

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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 NCT03093389 on ClinicalTrials.gov