NCT04200573

Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855

A Phase 1, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Ampreloxetine Following a Single-dose in Subjects With Mild, Moderate, and Severe Hepatic Impairment and in Matching Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a multicenter, non-randomized, open label, parallel group, single dose, 2-part study being conducted in adult subjects with mild, moderate, or severe HI (Child-Pugh Class A, B, and C), and in matching healthy subjects. The healthy matching group will be comparable to the corresponding hepatic impairment groups by matching subjects by weight (±20% of group mean), age (±10 years of group mean), and sex (equal ratios across groups). The study will be conducted in two sequential parts: In Part A, following a 28-day screening period, 6 subjects each with mild or moderate HI and 6 matching healthy subjects who meet eligibility criteria will be enrolled and administered a single Dose A (Day 1). In Part B, following a 28-day screening period, 6 subjects with severe hepatic impairment will receive a single Dose A (Day 1). Furthermore, the Sponsor may choose to enroll up to 6 additional healthy subjects in Part B to ensure matching of subjects across all groups for weight, age, and sex is maintained.

Conditions

• Symptomatic Neurogenic Orthostatic Hypertension
• nOH

Interventions

Type	Name	Description
DRUG	Ampreloxetine	The study drug will be administered orally as a single Dose A tablet

Timeline

• Start date: 2020-01-13
• Primary completion: 2021-08-19
• Completion: 2021-08-19
• First posted: 2019-12-16
• Last updated: 2021-09-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study