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.

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. - BIA 28-6156 & L-Dopa plus Carbidopa or Benserazide DDI in healthy subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50655

Enrollment

Registered

2021-11-16

Start date

2021-11-29

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's progressive nervous system disorder that affects movement

Interventions

Group 1: • On Day 1: a single dose of 100 mg of levodopa and 25 mg of carbidopa • On Day 2 to 6: a daily single dose of 60 mg BIA 28-6156 • On Day 7: a single dose of 60 mg BIA 28-6156 and a single

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- To investigate the effects of multiple doses of BIA 28-6156 on the single-dose PK of Sinemet® (100 mg of levodopa and 25 mg of carbidopa) in healthy male and female subjects. - To investigate the effects of multiple doses of BIA 28-6156 on the single-dose PK of Madopar® (levodopa 100 mg and benserazide 25 mg) in healthy male and female subjects.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)