A NON-RANDOMIZED, OPEN-LABEL, CROSS-OVER, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF BIA 28-6156 AT STEADY-STATE ON THE PHARMACOKINETICS OF LEVODOPA/CARBIDOPA AND LEVODOPA/BENSERAZIDE IN HEALTHY SUBJECTS.

Completed

Conditions: Parkinson's
progressive nervous system disorder that affects movement
10028037

Registration Number: NL-OMON50655

Lead Sponsor: BIAL R&D INVESTMENTS, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Sex: Male or female; females must be of nonchildbearing potential or
postmenopausal.
2. Age: 18 to 75 years, inclusive, at time of consent.
3. Body mass index: 18.0 to 32.0 kg/m2, inclusive, at screening.
4. Weight: >=50 kg at screening.
5. Status : Healthy subjects.

+ Further criteria apply.

Exclusion Criteria

1. Employee of PRA Health Sciences (PRA) or the Sponsor.
2. History of relevant drug and/or food allergies.
3. History of alcohol abuse or drug addiction (including soft drugs like
cannabis products) within 2 years prior to the first drug administration in the
current study.
4. Using tobacco or nicotine products within 14 days prior to the first drug
administration in the current study.
5. History of liver disease, previous bone marrow depression, hypersensitivity
to levodopa/carbidopa, or hypersensitivity to levodopa/benserazide.

+ Further criteria apply.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To investigate the effects of multiple doses of BIA 28-6156 on the<br /><br>single-dose PK of Sinemet® (100 mg of levodopa and 25 mg of carbidopa) in<br /><br>healthy male and female subjects.<br /><br><br /><br>- To investigate the effects of multiple doses of BIA 28-6156 on the<br /><br>single-dose PK of Madopar® (levodopa 100 mg and benserazide 25 mg) in healthy<br /><br>male and female subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the safety and tolerability of co-administration of BIA 28-6156<br /><br>with single-dose Sinemet® (100 mg of levodopa and 25 mg of carbidopa)<br /><br>- To assess the safety and tolerability of co-administration of BIA 28-6156<br /><br>with single-dose Madopar® (levodopa 100 mg and benserazide 25 mg)<br /><br>- To investigate the effects of multiple doses of BIA 28-6156 on PK of<br /><br>metabolite, 3-O-M.</p><br>