Evaluation of the Effects of Exendin-4 Fc Fusion Protein (JY09) Injection on the Pharmacokinetic Profiles of Metformin Hydrochloride Tablets, Rosuvastatin Calcium Tablets, and Digoxin Tablets and on the QT Interval in Overweight Chinese Subjects

Registration

Registration

NCT06247748

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

28

Start

2023-10-19

Primary completion

2024-04-15

Lead sponsor

Beijing Dongfang Biotech Co., Ltd.

Conditions

Diabetes Mellitus, Type 2; Overweight

Interventions

DRUG:Exendin-4 Fc fusion protein (JY09) injection; DRUG:Metformin Hydrochloride tablet; DRUG:Rosuvastatin calcium tablets; DRUG:Digoxin tablet

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• The Metformin Peak Concentration (Cmax ) [During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)]
• Area under the Metformin blood concentration-time curve [During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)]
• The Rosuvastatin Peak Concentration (Cmax ) [From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)]
• Area under the Rosuvastatin blood concentration-time curve [From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)]
• The Digoxin Peak Concentration (Cmax ) [From time 0 to 168 hours after a single dose of Digoxin without JY09 exposure (Day 15) and at JY09 steady state (Day 102)]
• Baseline-corrected difference of Corrected QT interval after multiple subcutaneous injections of JY09 injection [From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92)]