Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.
NCT04622111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2021-08-18
Summary
The planned study is to determine the safety and pharmacokinetic properties of CPL207280 compound after single and multiple (two weeks) administration in healthy volunteers.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
CPL207280
IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).
- DRUG
-
matching placebo tablet
- DRUG
-
Metformin hydrochloride 750 mg
IMP is a tablet with Metformin hydrochloride as an Active Pharmaceutical Ingredient (API).
Sponsors & Collaborators
-
National Center for Research and Development, Poland
collaborator OTHER -
Celon Pharma SA
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-05-27
- Primary Completion
- 2021-04-01
- Completion
- 2021-05-05
Countries
- Poland
Study Locations
More Related Trials
-
CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)
NCT03317028 ·Status: COMPLETED ·Phase: PHASE2
-
Metformin Therapy in Type 1 Diabetes Mellitus.
NCT01889706 ·Status: UNKNOWN
-
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy
NCT00638716 ·Status: COMPLETED ·Phase: PHASE2
-
Drug-Drug Interaction Study to Evaluate the Effect of PF-06865571 on Metformin Pharmacokinetics
NCT03593707 ·Status: COMPLETED ·Phase: PHASE1
-
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
NCT03538743 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
NCT00511667 ·Status: COMPLETED ·Phase: PHASE1
-
PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults
NCT07300007 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers
NCT01756417 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
NCT00971243 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Effect of RG1662 on Metformin in Healthy Volunteers
NCT02342925 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly
NCT02125305 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
NCT01540487 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
NCT05729386 ·Status: UNKNOWN ·Phase: PHASE1
-
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers
NCT02931214 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
NCT01376557 ·Status: COMPLETED ·Phase: PHASE2
-
A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
NCT01273571 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263
NCT01128621 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs
NCT03787017 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
NCT01046422 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects
NCT05526690 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Profiles of Metformin With DW1029M
NCT02212756 ·Status: COMPLETED ·Phase: PHASE1
-
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
NCT02656017 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
NCT00694057 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
NCT04218734 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
NCT01111955 ·Status: COMPLETED ·Phase: PHASE2