A Multi-center, Parallel Cohort, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HDM1002 in Subjects With Normal Hepatic Function and Hepatic Impairment.

Registration

Registration

NCT06985615

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

RECRUITING

Enrollment

40

Start

2025-03-18

Primary completion

2026-01-14

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Conditions

Hepatic Impairment; Healthy Volunteers

Interventions

DRUG:Single dose of HDM1002 on Day 1

Results posted

FALSE

Registered primary outcomes

• Maximum Plasma Concentration (Cmax) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.]
• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.]
• Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.]
• Fraction of Unbound Drug in Plasma (fu) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.]