Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 19, 2023

Primary Completion Date

April 15, 2024

Study Completion Date

April 15, 2024

Conditions
Diabetes Mellitus, Type 2Overweight
Interventions
DRUG

Exendin-4 Fc fusion protein (JY09) injection

D22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29, D36, D43, D50, D57, D64, D71, and D78 subjects returned to the study center to receive a subcutaneous abdominal injection of 2.4 mg of JY09 injection(total of 8 administrations).All doses were to be administered within 3 min.

DRUG

Metformin Hydrochloride tablet

D1 to D4 continuous oral administration of 0.5 g metformin hydrochloride tablets twice daily (D4 was administered only in the morning, with a total of 7 administrations) for a washout period of 96 h;0.5 g metformin hydrochloride tablets orally twice a day continuously from D85 to D88 (D88 was given only in the morning, for a total of 7 doses).

DRUG

Rosuvastatin calcium tablets

D8 received a single oral administration of 10 mg of Rosuvastatin calcium tablets in the morning, with a washout period of 168 h,and 10 mg Rosuvastatin calcium tablets orally at 72 h ± 0.5 h (D95) after JY09 administration.

DRUG

Digoxin tablet

D15 received a single oral administration of 0.25 mg digoxin tablets in the morning, with a washout period of 168 h,oral 0.25 mg digoxin tablets 72 h±0.5 h after JY09 administration (D102)

Trial Locations (1)

Unknown

Peking University Third Hospital drug clinical trial Institute, Beijing

All Listed Sponsors
lead

Beijing Dongfang Biotech Co., Ltd.

INDUSTRY

NCT06247748 - Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects | Biotech Hunter | Biotech Hunter