Study identifier:CIN-107-114
ClinicalTrials.gov identifier:NCT05526690
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Open-Label, Two-Period, Crossover Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects
hypertension
Phase 1
Yes
Metformin, CIN-107
All
27
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Treatment A: Immediate-release metformin Treatment A: single 1000 mg dose of immediate-release metformin Subjects will be randomly assigned to 1 of 2 sequences: AB or BA. • Treatment A: a single 1000 mg dose of immediate-release metformin; and • Treatment B: a single 1000 mg dose of immediate-release metformin coadministered with a 10 mg dose of CIN-107. All study medication will be administered at 8:00 AM (±2 hours). There will be a minimum 10-day washout between administration of study drug in each treatment period. | Drug: Metformin 1000 mg dose of immediate-release metformin |
Experimental: Treatment B: Immediate-release metformin coadministered with a CIN-107 Treatment B: a single 1000 mg dose of immediate-release metformin coadministered with a 10 mg dose of CIN-107 Subjects will be randomly assigned to 1 of 2 sequences: AB or BA. • Treatment A: a single 1000 mg dose of immediate-release metformin; and • Treatment B: a single 1000 mg dose of immediate-release metformin coadministered with a 10 mg dose of CIN-107. All study medication will be administered at 8:00 AM (±2 hours). For Treatment B, the dose of CIN-107 will be administered 2 hours prior to the dose of metformin. There will be a minimum 10-day washout between administration of study drug in each treatment period. | Drug: Metformin 1000 mg dose of immediate-release metformin Drug: CIN-107 10 mg dose of CIN-107 |