CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
BIA 9-1067 +2 moredrug
Likely dose
BIA 9-1067 at three different single doses (specific doses not stated) and levodopa/benserazide 100/25 mg single doseAI-extracted
Key inclusion· 6
  • ✓Male volunteers aged 25-45 years
  • ✓BMI ≥19 and <30 kg/m²
  • ✓Non- or ex-smokers (quit ≥12 months prior)
  • ✓Healthy determined by medical history, physical exam, vitals, neurological exam, and ECG
Key exclusion· 13
  • ✕Clinically relevant surgical, family, or atopy history
  • ✕Active infection or inflammatory process
  • ✕Acute GI symptoms (nausea, vomiting, diarrhea, heartburn)
  • ✕Vegetarian, vegan, or medical dietary restrictions

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02169895
NCT02169895Phase 1Completed
CompareCT.gov

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Bial - Portela C S.A.·interventional·Posted Jun 23, 2014·Updated Jan 15, 2015

In Brief

A Phase 1 clinical trial evaluating BIA 9-1067, Placebo, and 1 other intervention for Parkinson's Disease (PD). Completed, enrolled 16 participants across 1 site.

Detailed Summary

To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease (PD)
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartSep 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.0 years ago

Interventions

BIA 9-1067drug

Placebodrug

Prolopa®drug

levodopa/benserazide 100/25 mg