A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects

NCT02604914 | Completed Phase 1

• 1 other identifier: ND0612-005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and to Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

• Cmax (maximal plasma concentration) of CD for different doses of CD

  Pre-infusion and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 20, 22, 24, 25, 26, 27, 28, 29, 30, 31, and 32 hours after commencing the ND0612 infusion on Days 1, 3 and 5.

  6 days

• AUC (area under the curve) of CD for different doses of CD

  Pre-infusion and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 20, 22, 24, 25, 26, 27, 28, 29, 30, 31, and 32 hours after commencing the ND0612 infusion on Days 1, 3 and 5.

  6 days

• Cmax (maximal plasma concentration) of LD and CD for ND0612 vs. LCIG

  Pre-infusion and at 1, 2, 3, 4, 6, 9, 12, 14, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after commencing the LCIG infusion on Days 1 and 3.

  4 days

• AUC (area under the curve) of LD and CD for ND0612. LCIG

  Pre-infusion and at 1, 2, 3, 4, 6, 9, 12, 14, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after commencing the LCIG infusion on Days 1 and 3.

  4 days

Study Arms (3)

ND0612L (LD/CD solution)

EXPERIMENTAL

3 doses of the investigational ND0612L (LD/CD solution) for subcutaneous (SC) infusion 0.24ml per hour.

Drug: ND0612

ND0612H (LD/CD solution)

EXPERIMENTAL

3 doses of the investigational ND0612H (LD/CD solution) for subcutaneous (SC) infusion 0.64ml per hour.

Drug: ND0612

LCIG (Levodopa-carbidopa intestinal gel)

ACTIVE COMPARATOR

Active Comparator: LCIG subjects who completed the ND0612H arm will be administered with 3 doses of LCIG, directly to the jejunum.

Drug: LCIG

Interventions

ND0612 DRUG

Subcutaneous solution

Also known as: (Levodopa-Carbidopa solution)

ND0612H (LD/CD solution); ND0612L (LD/CD solution)

LCIG DRUG

Intrajejunal Gel

Also known as: (Levodopa-Carbidopa Intestinal Gel)

LCIG (Levodopa-carbidopa intestinal gel)

Eligibility Criteria

• Age: 30 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 32.0 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 (Part 1 only for subjects assigned to ND0612L and Part 1 and Part 2 for subjects assigned to ND0612H)
• Must provide written informed consent
• Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration)
• Must agree to use an adequate method of contraception
• \. Subjects who were dosed with ND0612H (any replacements subjects enrolled in Part 2 will be dosed with the optimal LD/CD concentration of ND0612H after completion of Part 2).

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
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• 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

Sponsors & Collaborators

• NeuroDerm Ltd.: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical LTD

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip evans, MBChB, MRCS

  Quotient Clinical LTD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 16, 2015
• Study Start: May 29, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

GB (1)