Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Study Overview
Brief Summary
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).
- •Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)
- •Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)
- •Group 3: Healthy subjects with normal hepatic function
- •Other pre-defined inclusion and exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with mild hepatic impairment (Group1)
8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054
Intervention: Lu AE58054 encapsulated film-coated tablets (Drug)
Patients with moderate hepatic impairment (Group 2)
8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.
Intervention: Lu AE58054 encapsulated film-coated tablets (Drug)
Healthy subjects (Group 3)
8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.
Intervention: Lu AE58054 encapsulated film-coated tablets (Drug)
Outcomes
Primary Outcomes
Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time Frame: 0 to 96 hours
Maximum observed plasma concentration (Cmax) of Lu AE58054
Time Frame: 0 to 96 hours
Secondary Outcomes
- Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)(Screening to day 11)