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 range18 Years – 80 Years
SexALL
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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…
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