Status:
WITHDRAWN
A Multi-Center, Open-Label Study
Lead Sponsor:
Chelsea Therapeutics
Conditions:
Renal Disease
End Stage Renal Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction a...
Detailed Description
Introduction Droxidopa (L-DOPS) is an orally administered, synthetic catecholamine that is converted to the sympathetic neurotransmitter norepinephrine (NE) through a single step of decarboxylation by...
Eligibility Criteria
Inclusion
- Informed Consent
- Male or Female between 18 and 79 years
- Female subject of childbearing potential not surgically sterile or min 2 years postmenopausal must use approved contraceptives
- BMI 20 to 40 kg per m2
- Refrain from exercise
- eGFR per protocol for condition
- Sufficient venous access
- Stable medication dosing 14 days prior to and during study
- Healthy control subjects must show good general health per protocol
- Subjects will be matched Healthy to Renal Impaired by demographics data
Exclusion
- Inability to complete study
- Insufficient venous access
- Clinically significant illness within 4 weeks of study
- History of clinically unstable disease except renal impairment in those subjects
- Medical or surgical conditions that may inhibit absorption of IP
- Laboratory value or medical issue which may interfere with study data or be hazardous for the subject
- Medication that may interfere with drug absorption or elimination process 4 weeks prior to study
- Consumption of grapefruit products within 7 days prior and after study
- Dose changes of medications 14 days prior to and during study
- Active alcohol abuse or drug addiction
- Positive alcohol test at screening or after
- Excessive xanthine consumption
- Positive serology test Hepatitis B or Hepatitis C or HIV
- Excessive nicotine usage
- Positive urine screen for drugs of abuse without prescription
- Clinically relevant abnormal 12 lead ECG
- Donation of bood or plasma or platelets within 30 days of study
- Clinical trial with another agent within 30 days or 5 half lives whichever is longer
- Informed consent unavailable or withdrawn
- Any condition the investigator feels would interfere with study data or subjects health
- Employee or relative of study center or center staff or investigator
- Any condition that may increase risk for subject
- Clinically significant lab value
- Clinically significant acute or chronic disease other than renal impairment in those subjects that may interfere with data or health
- Medication dose change within 14 days of study
- Seated BP greater than 180 over 105
- Healthy subject with history of renal impairment
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01468259
Start Date
October 1 2012
End Date
December 1 2012
Last Update
March 29 2013
Active Locations (1)
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1
NOCCR
Knoxville, Tennessee, United States, 37920