- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149629
Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa
A Randomized, Open-Label, Three-Period, Three-Sequence, Single-Dose Crossover and Separate Three-Daily-Dose Treatment Period Study Comparing the Pharmacokinetic Profiles Following Oral Dosing of 300 mg of Droxidopa in the Fed Versus Fasted State, the Bioequivalence of Three 100 mg Capsules of Droxidopa Versus a Single 300 mg Capsule of Droxidopa, and 300 mg of Droxidopa Given Three Times at Four Hour Intervals in Healthy, Elderly Subjects
One purpose of this study is to determine if taking droxidopa after eating will have an effect on how the body processes (absorbs and eliminates) the drug in healthy elderly subjects. Another purpose of this study is to see how the body processes (absorbs and eliminates) one 300mg capsule compared to three 100mg capsules. This study will also evaluate how well the body processes (absorbs and eliminates) and tolerates droxidopa when a 300 mg capsule is given 3 times a day for a total dose of 900 mg over the course of one day.
Droxidopa is used to treat low blood pressure upon standing in patients with diseases of the nervous system, to prevent low blood pressure in patients with kidney disease during hemodialysis (removal of waste products of the blood), and to treat frozen gait (walking, stepping or running) and dizziness upon standing in patients with Parkinson's disease.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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North Dakota
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Fargo, North Dakota, United States, 58104
- Cetero Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provide written consent on an IRB-approved Informed Consent Form (ICF), prior to any study-specific evaluation. Subjects should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.
- Male or female ≥65 years of age.
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive.
- If female, not pregnant (or lactating), as evidenced by a negative serum pregnancy test, and is surgically sterile (hysterectomy, bilateral ovariectomy, or bilateral tubal ligation), or at least 2 years postmenopausal.
- Ability and willingness to abstain from alcohol from 48 h prior to the first dose until the completion of the study.
- No clinically significant abnormalities on the basis of medical history, physical examination, and vital signs unless currently controlled with medical treatment (e.g., a stable medication dosing regimen).
- Computerized, 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations, as judged by the investigator.
- All values for hematology, clinical chemistry, and urinalysis are normal or if abnormal-are deemed not clinically significant as judged by a physician investigator with documented agreement from the Medical Monitor.
- Nonsmoking or have quit smoking at least 6 months prior to dosing.
Exclusion Criteria:
- Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease not currently controlled with medical treatment (e.g., a stable medication dosing regimen).
- Presence of an active malignancy of any type other than nonmelanomatous skin malignancies.
- History of relevant drug and/or food allergies.
- Recent history (past 5 years) of alcohol abuse or drug addiction.
- Required use of concomitant medications that could confound the PK or safety evaluation, such as medications that affect GI function (including proton pump inhibitors or metoclopramide) or vasoconstricting agents (e.g., ephedrine, dihydroergotamine, or midodrine), -triptans (e.g., sumatriptan, naratriptan, zolmitriptan, rizatriptan), halogen-containing anesthetics (e.g., cyclopropane, or halothane), catecholaminecontaining preparations (e.g., isoprenaline), non-selective MAOIs, ergotamine derivatives (except for anti-Parkinson medications), or any drugs with anti-hypertensive properties that in the investigator's opinion, could significantly contribute to the subject's orthostatic hypotension.
- Participation in an investigational drug study within 30 days prior to study drug administration.
- Donated a unit of blood (500 mL) or plasma within the 30-day period prior to the initial dose of study medication or who intend to donate blood or plasma within a 30-day period following the final dose of study medication.
- Positive screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines) or alcohol.
- Positive screen for urine cotinine.
- Positive screen for hepatitis B surface antigen.
- Positive screen for antibodies to hepatitis C virus.
- Positive screen for antibodies to human immunodeficiency virus (HIV-1/HIV-2).
- Acute illness within 5 days prior to drug administration.
- History of coagulation disorder, thrombocytopenia, bleeding tendency, or gastrointestinal bleeding.
- Professional or ancillary personnel involved in the study.
- In the opinion of the investigator, not suitable for entry into the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fed Dosing
Subjects fed a high calorie, high fat meal prior to receiving 3 x 100mg capsules
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One capsule containing 300 mg droxidopa, given once
3 capsules each containing 100 mg droxidopa, give 3 times at 4 hour intervals
3 capsules each containing 100 mg droxidopa, given once
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Active Comparator: Fasted Dosing
Subjects fasted prior to receiving 3 x 100mg capsules
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One capsule containing 300 mg droxidopa, given once
3 capsules each containing 100 mg droxidopa, give 3 times at 4 hour intervals
3 capsules each containing 100 mg droxidopa, given once
|
Active Comparator: Bioequivalence
Subjects fasted prior to receiving 1x 300mg capsule
|
One capsule containing 300 mg droxidopa, given once
3 capsules each containing 100 mg droxidopa, give 3 times at 4 hour intervals
3 capsules each containing 100 mg droxidopa, given once
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Active Comparator: TID Dosing
Droxidopa 300 mg given TID
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One capsule containing 300 mg droxidopa, given once
3 capsules each containing 100 mg droxidopa, give 3 times at 4 hour intervals
3 capsules each containing 100 mg droxidopa, given once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Droxidopa Pharmacokinetics
Time Frame: 24 hours
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Blood samples will be collected at the time from 0 to 24 hours.
Cmax, Tmax, AUC(0-∞), AUC(0-t), t1/2, and CL/F, will be determined for plasma concentrations of droxidopa in Parts I and II and will also be determined for two of its metabolites (3-OM-droxidopa and norepinephrine) in Part II only.
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregory M Haugen, M.D., Cetero Research, San Antonio
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Droxidopa NOH101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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