Abstract: TH-PO897
Effect of Food on the Pharmacokinetics of AND017 in a Phase I Study
Session Information
- Anemia and Iron Metabolism
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Zhu, Yusha, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Zhang, Hua, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
- Du, Ping, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Zhu, Qi, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Miao, Liyan, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Background
AND017 is a novel hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) independently developed by Kind Pharmaceuticals LLC and is an emerging new option of treatment for anemia due to chronic kidney disease (CKD). The effect of food on the pharmacokinetics (PKs) of AND017 was investigated in a Phase I study (NCT04712500).
Methods
This is a Phase I, randomized, open-labeled, two-sequence, two-period, crossover study conducted among healthy non-elderly volunteers in China. The primary objective was to evaluate the effect of food on the PKs of a single oral dose of 10 mg of AND017.
The study consisted of two periods with a 5-day washout in between. Healthy volunteers were randomized at 1:1 to receive a single dose of 10 mg AND017 under fasted (sequence A) or fed conditions (sequence B) in the first study period. After a 5-day washout, volunteers received another single dose of 10 mg of AND017 under fed (sequence A) or fasted (sequence B) conditions in the second study period. PK samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 h post-dose after each dose. Safety was assessed by monitoring adverse events (AEs), clinical laboratory tests (hematology, chemistry, urinalysis, and coagulation), vital signs, 12-lead ECGs, and physical examinations.
Results
In the study, a total of 14 healthy volunteers were enrolled with similar demographics and baseline characteristics. There were no significant differences in the PK parameters when AND017 was administered under fed and fasted conditions, except for a 20% reduction of Cmax under fed condition compared to the fasted condition; the geometric mean ratio (fed/fasted) and 90% CI for Cmax and AUC0-inf were 79.61% (73.40,86.34) and 99.93% (96.31,103.68) respectively.
In the safety analysis, a total of 7 volunteers reported 12 TEAEs, among which 4 TEAEs reported by 3 volunteers were determined to be treatment-related, which were alanine aminotransferase increased, diastolic pressure decreased, triglycerides high, and creatine kinase increased, with each reported once and CTCAE grade ≤2. No AE leading to discontinuation or SAE occurred in the study.
Conclusion
In summary, a single dose of AND017 at 10 mg administered alone or in combination with food was generally safe and well-tolerated in healthy non-elderly volunteers. The study supports the safe use of AND017 under fed or fasted conditions.