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

NCT02604914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-01-18

No results posted yet for this study

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

Interventions

DRUG

ND0612

Subcutaneous solution

DRUG

LCIG

Intrajejunal Gel

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • NeuroDerm Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip evans, MBChB, MRCS · Quotient Clinical LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604914 on ClinicalTrials.gov