Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05459688 | Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124 | PHASE2 | COMPLETED | 175 | — | — | Apr 6, 2022 | Nov 7, 2023 | Dec 16, 2024 | 36 | United States |
| NCT05470725 | Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function | PHASE1 | COMPLETED | 33 | — | — | Jan 12, 2021 | Apr 30, 2021 | Aug 14, 2023 | 2 | United States |
| NCT05526690 | Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects | PHASE1 | COMPLETED | 27 | — | — | Oct 28, 2020 | Dec 12, 2020 | Aug 14, 2023 | 1 | United States |
| NCT05500820 | Study With CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects | PHASE1 | COMPLETED | 56 | — | — | Dec 19, 2019 | Apr 3, 2020 | Aug 14, 2023 | 1 | United States |
An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product. Any medical condition already present at enrollment should be recorded as medical history and not be reported as an AE unless the medical condition or signs or symptoms present at baseline changes in severity, frequency, or seriousness at any time during the study. In this case, it was be reported as an AE.
For this study, AESIs include the following: Events of hypotension that require clinical intervention; Abnormal potassium laboratory values that require clinical intervention; and Abnormal sodium laboratory values that require clinical intervention.
An AE was or adverse reaction is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: Death, a life-threatening AE, a persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, or an important medical event.
Mean change from baseline at Week 52 in serum potassium (mmol/L).
Mean change from baseline at Week 52 in serum sodium (mmol/L).
Change from baseline at 52 weeks in body weight (kg)
Change from baseline at 52 weeks in temperature (C)
Change from baseline at 52 weeks in seated heart rate (beats/min)
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107 using plasma concentration data.
This PK parameter will be determined for CIN-107 using plasma concentration data.
This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
Calculated as Ae/AUC. This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
This PK parameter will be calculated using the urine concentrations of CIN-107
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This urine PK parameter will be determined for metformin.
This urine PK parameter will be determined for metformin.
This urine PK parameter will be determined for metformin.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first dose of CIN-107, as the data permit.
This PK parameter will be determined for CIN-107 using plasma concentration data.
This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
This PK parameter will be calculated using the urine concentrations of CIN-107
| Arm | Type | Description |
|---|---|---|
| Experimental 2 mg CIN-107 tablets QD | EXPERIMENTAL | Treatment with 2 mg CIN-107 tablets, by mouth, once per day. Starting at Visit 1 and concluding at EOT (Visit 7). |
| Control (normal renal function or mild renal impairment) | EXPERIMENTAL | Estimated glomerular filtration rate (eGFR) ≥60 mL/min |
| Moderate to severe renal impairment | EXPERIMENTAL | eGFR 15 to 59 mL/min |
| Kidney failure | EXPERIMENTAL | eGFR \<15 mL/min, including: * Subjects not on dialysis; and * Subjects on dialysis, with study drug administration on a non-dialysis day |
| Treatment A: Immediate-release metformin | ACTIVE_COMPARATOR | 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. |
| Treatment B: Immediate-release metformin coadministered with a CIN-107 | EXPERIMENTAL | 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. |
| Cohort 1: 2.5 mg CIN-107 | EXPERIMENTAL | Subjects on a low salt diet |
| Cohort 2: 5.0 mg CIN-107 | EXPERIMENTAL | Subjects on a low salt diet |
| Cohort 3: 1.5 mg CIN-107 | EXPERIMENTAL | Subjects on a normal salt diet |
| Cohort 4: 2.5 mg CIN-107 | EXPERIMENTAL | Subjects on a normal salt diet |
| Cohort 5: 0.5 mg CIN-107 | EXPERIMENTAL | Subjects on a normal salt diet |
| Cohort 1: 2.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a low salt diet |
| Cohort 2: 5.0 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a low salt diet |
| Cohort 3: 1.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a normal salt diet |
| Cohort 4: 2.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a normal salt diet |
| Cohort 5: 0.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a normal salt diet |
| Name | Type | Description |
|---|---|---|
| CIN-107 | DRUG | 2 mg of CIN-107, once a day for 52 weeks |
| Metformin | DRUG | 1000 mg dose of immediate-release metformin |
| Matching Placebo | DRUG | A repeat oral dose of matching placebo once daily for 10 days. |
Inclusion Criteria: 1. Have completed Part 1 or Part 2 of Study CIN-107-124; 2. Have had acceptable safety and tolerability during Study CIN-107-124 as determined by the Investigator or Medical Monitor; 3. Have demonstrated ≥70% and ≤120% adherence to their single background antihypertensive agent ...