A Multi-Center, Open-Label Study
Public ClinicalTrials.gov record NCT01468259. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Multi-Center, Open-Label Study to Examine the Pharmacokinetics of a Single Dose of Droxidopa in Subjects With Renal Impairment Compared to Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 and End Stage Renal Disease (ESRD) after a single dose compared to matched healthy subjects with normal renal function. A total of 48 male or female subjects, 16 subjects with normal renal function (eGFR greater than 90 mL/min/1.73m²) and eight each (8) with mild (60 less than eGFR less than 89 mL/min/1.73m²), moderate (30 less than eGFR less than 59 mL/min/1.73m²), or severe (15 less than eGFR less than 29 mL/min/1.73m²) renal impairment or ESRD (eGFR \< 15 mL/min/1.73m² and requiring hemodialysis) will be selected according to the inclusion and exclusion criteria. The medical and laboratory examinations will take place within 28 days before dosing. A single dose of 600 mg of droxidopa as an investigational drug will be administered with 240 mL of water after an overnight fast (minimum 10 hours). Blood samples for the measurement of plasma concentrations of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours after dosing for healthy volunteers and subjects with mild, moderate, and severe renal impairment and those with ESRD. For the latter, samples will be collected on both a non-hemodialysis and a hemodialysis visit. During dialysis, samples of dialysate, from the arterial and venous sides of the dialyzer will be collected at 30-minute intervals during the dialysis period. In addition, the entire dialysate will be collected, its volume recorded, and a sample retained for the measurement of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid concentrations. Urine samples for the measurement of urinary excretion of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected before and over the following intervals after dosing: 0 2, 2-4, 4-6, 6-8, 8-12, 12-24, and 24-36 hours for healthy volunteers and subjects with mild, moderate, and severe renal impairment. A post-study visit with physical examination and laboratory tests will take place within seven (7) days after the last PK blood sampling.
Study identification
- NCT ID
- NCT01468259
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2012
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
- Last update posted
- Mar 28, 2013
2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NOCCR | Knoxville | Tennessee | 37920 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01468259, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2013 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01468259 live on ClinicalTrials.gov.