Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855 (NCT04200573) | Clinical Trial Compass
CompletedPhase 1
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
United States31 participantsStarted 2020-01-13
Plain-language summary
An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All Subjects:
* has a body mass index (BMI) of 19 to 40 kg/m2, inclusive, and weight of at least 55 kg.
* clinical labs within normal ranges
* creatinine clearance of \>70 mL/min
* women must be non-pregnant and non-lactating, male and females must agree to highly effective methods of contraception
* additional criteria apply
Subjects with Impaired Hepatic Function additional criteria:
* Subject has mild (Child-Pugh Class A \[5 to 6 points\]), moderate (Child-Pugh Class B \[7 to 9 points\]), or severe (Child-Pugh Class C \[10-15 points\]) liver disease
* has stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days
* must be on a stable dose of medication and/or treatment regimen at least 30 days before dosing
* Additional inclusion criteria apply
Exclusion Criteria:
Subjects with normal hepatic function:
* history of reactions or hypersensitivity to ampreloxetine or known intolerance to other norepinephrine reuptake inhibitors (NRI) or serotonin norepinephrine reuptake inhibitors (SNRI).
* personal or family history of congenital long QT syndrome
* history of untreated closed angle glaucoma
* history of orthostatic hypotension or orthostatic tachycardia or a history of dizziness, lightheadedness or fainting, or a feeling of blacking out upon standing
* has used nephrotoxic or hepatotoxic medications 30 days before Day-2
* routinely uses more than 2 grams of acetaminophen daily
* has used tobacco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma AUC0-t
Timeframe: Plasma AUC0-t will be measured Day 1 to Day 15
2
Plasma AUC0-inf
Timeframe: Plasma AUC0-inf will be measured from Day 1 to Day 15