A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)

NCT02486432 | Completed Phase 1

• 1 other identifier: ND0612-013
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• The objective of the study is to provide safety and tolerability information for oral doses of levodopa and carbidopa administered as a divided dose.

  Safety and tolerability will be assessed by: adverse events (AEs), physical examination, safety laboratory tests, vital signs and electrocardiograms (ECGs).

  5 weeks

Study Arms (1)

Single arm Levodopa/Carbidopa

EXPERIMENTAL

The intervention is dosing with Sinemet® which is an oral tablet containing Levodopa/Carbidopa. Oral administration of 2 × 12.5 mg/50 mg Sinemet® tablet containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa three times a day on Day -1 with 240 mL water Oral administration of 1 × 12.5 mg/50 mg Sinemet® tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered with 100 mL water every hour for 16 hours on Day 1

Drug: Levodopa/Carbidopa (Sinemet)

Interventions

Levodopa/Carbidopa (Sinemet) DRUG

Oral administration of 2 × 12.5 mg/50 mg Sinemet® tablet containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa three times a day on Day -1 with 240 mL water Oral administration of 1 × 12.5 mg/50 mg Sinemet® tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered with 100 mL water every hour for 16 hours on Day 1

Also known as: Sinemet

Single arm Levodopa/Carbidopa

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females
• Age 40 to 65 years of age
• Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception

You may not qualify if:

• Participation in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects who have previously been enrolled in this study
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
• Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days before IMP administration (See Section 11.4)

Sponsors & Collaborators

• NeuroDerm Ltd.: lead
• Quotient Clinical: collaborator

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Carbidopa; carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Study Officials

• Philip Evans, MBChB, MRCS

  Quotient Clinical Mere Way Ruddington Fields Ruddington Nottingham NG11 6JS, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 1, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06