Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

Parkinson Disease Clinical Trial

Official title:

A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519284
• Other study ID #: BIA-91067-114
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2012
• Last updated: July 22, 2015
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

Description:

Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Able and willing to give written informed consent.

• Male or female subjects aged between 18 and 45 years, inclusive.

• Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.

• Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

• Clinical laboratory test results clinically acceptable at screening and admission to the treatment period.

• Negative screen for alcohol and drugs of abuse at screening and admission to the treatment period.

• Non-smokers or ex-smokers for at least 3 months.

• (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner).

• (If female) She had a negative urine pregnancy test at screening and admission to the treatment period.

Exclusion Criteria:

• 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.

• Clinically relevant surgical history.

• Any abnormality in the coagulation tests.

• Any abnormality in the liver function tests.

• A history of relevant atopy or drug hypersensitivity.

• A history or presence of narrow-angle glaucoma.

• A suspicious undiagnosed skin lesions or a history of melanoma.

• History of alcoholism or drug abuse.

• Consumed more than 14 units of alcohol a week.

• Significant infection or known inflammatory process at screening or admission to the treatment period.

• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period.

• Had used non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of admission to the treatment period.

• Had used medicines within 2 weeks of admission to the treatment period that may have affected the safety or other study assessments, in the investigator's opinion.

• Had previously received BIA 9-1067.

• Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.

• Had participated in more than 2 clinical trials within the 12 months prior to screening.

• Had donated or received any blood or blood products within the 3 months prior to screening.

• Vegetarians, vegans or had medical dietary restrictions.

• Cannot communicate reliably with the investigator.

• Unlikely to co-operate with the requirements of the study.

• Unwilling or unable to gave written informed consent.

• (If female) She was pregnant or breast-feeding.

• (If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• BIA 9-1067 5 mg
BIA 9-1067 OPC, Opicapone 5 mg
• Entacapone
Entacapone 200 mg
• Placebo
placebo (four times a day)
• levodopa/carbidopa
standard release levodopa/carbidopa 100/25 mg (single-dose)
• BIA 9-1067 15 mg
BIA 9-1067 OPC, Opicapone 15 mg
• BIA 9-1067 30 mg
BIA 9-1067 OPC, Opicapone 30 mg

Locations

Country	Name	City	State
Portugal	Bial - Portela & Cª, S.A.	S. Mamede do Coronado

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Plasma Concentration of Levodopa	Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days	8 days	Yes
Secondary	Tmax - Time to Reach Maximum Plasma Concentration of Levodopa	Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.	8 days	Yes
Secondary	AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.	AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days	8 days	Yes
Secondary	AUC0-8 - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity	AUC0-8 - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.	8 days	Yes