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

Bial - Portela C S.A.1 site in 1 country22 target enrollmentStarted: January 2009Last updated: November 3, 2015

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 22
Locations: 1
Primary Endpoint: Tmax - Time to Cmax

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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 controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).

Detailed Description

Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Male subjects between 18 and 45 years, inclusive.
•Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
•Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
•Subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.
•Subjects who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
•Subjects who had/were negative for drugs of abuse at screening and admission to each treatment period.
•Subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day.
•Subjects who were able and willing to give written informed consent.

Exclusion Criteria

•Subjects who did not conform to the above inclusion criteria, or
•Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
•Subjects who had a clinically relevant surgical history.
•Subjects who had a clinically relevant family history.
•Subjects who had a history of relevant atopy.
•Subjects who had a history of relevant drug hypersensitivity.
•Subjects who had a history of glaucoma.
•Subjects who had a history of alcoholism or drug abuse.
•Subjects who consumed more than 21 units of alcohol a week.
•Subjects who had a significant infection or known inflammatory process on screening or first admission.
•Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
•Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
•Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
•Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
•Subjects who were vegetarians, vegans or have medical dietary restrictions.
•Subjects who could not communicate reliably with the investigator.
•Subjects who were unlikely to co-operate with the requirements of the study.
•Subjects who were unwilling or unable to give written informed consent.
•Subjects who were BIAL - Portela & Cª, SA employees.