Fazamorexant Pharmacokinetics in Chinese Patients with Hepatic Impairment

24 participants completed a non-randomized, open-label study assessing the impact of mild or moderate hepatic impairment on the pharmacokinetics of the insomnia drug Fazamorexant. The dataset, authored by Qingmei Li and last updated in April 2026, contains results showing a 50% increase in drug exposure (AUC) for patients with hepatic impairment compared to healthy controls. Fazamorexant was generally well tolerated, with minimal impact on peak plasma concentration.

Use Cases

• Building PBPK models for dose adjustment based on pharmacokinetic parameters (Cmax, AUC) in hepatic impairment.
• Analyzing drug safety and tolerability profiles based on the single-dose study design in a controlled cohort.
• Comparing drug exposure metrics between healthy subjects and patients with Child-Pugh class A or B liver disease.
• Validating clinical dosing guidance for dual orexin receptor antagonists in populations with organ impairment.

Strengths

• Includes pharmacokinetic data for 24 participants across three matched groups (8 per group).
• Provides geometric mean ratios with 90% confidence intervals for key metrics like Cmax and AUC.
• Study design is clearly described as a single-dose, non-randomized, open-label trial.
• Dataset is openly licensed under CC-BY-4.0, permitting reuse and redistribution.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment for large-scale modeling.
• Data is contained in a DOCX file (211.8 KB), suggesting a small-scale, document-based summary rather than raw structured data tables.

Provenance

Source

figshare, authored by Qingmei Li.

Collection Method

Data appears to be derived from a clinical study using a non-randomized, open-label, single-dose design.

Time Range

The study completion date is not specified, but the dataset was last updated in April 2026.

Freshness

Last updated 2026-04-24 07:12:12; freshness should be verified.

Geography

Study conducted with Chinese patients and healthy controls.