Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KBP-5074 · 7 trials · 7 indications
Change in trough cuff resting seated SBP from baseline to Day 84.
Rate of adverse events
Percentage of total radioactivity recovered in urine and feces following a single dose \[14C\]-KBP-5074
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Time of the maximum observed concentration (Cmax) - Plasma
Maximum observed concentration (Cmax) - Plasma
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable plasma concentration
Physical exam, vital signs, EKG, clinical laboratory tests, adverse events
Assessing the number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): pre dose and post dose
Assessing drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose
| Arm | Type | Description |
|---|---|---|
| KBP-5074 0.25 mg tablet | EXPERIMENTAL | KBP-5074 0.25 mg tablet QD orally, 84 days |
| KBP-5074 0.5 mg tablet | EXPERIMENTAL | KBP-5074 0.5 mg tablet QD orally, 84 days |
| Placebo tablet | PLACEBO_COMPARATOR | Placebo tablet QD orally, 84 days |
| Cohort 1 | EXPERIMENTAL | Healthy Volunteers will receive 2.5mg of KBP-5074, QD, 14 days |
| Cohort 2 | EXPERIMENTAL | Healthy Volunteers will receive 5.0mg of KBP-5074, QD, 14 days |
| Cohort 3 | EXPERIMENTAL | Subjects with mild to moderate renal impairment will receive 0.5mg of KBP-5074, QD, 56 days |
| Cohort 4 | EXPERIMENTAL | Subjects with mild to moderate renal impairment will receive 2.5mg of KBP-5074, QD, 56 days |
| [14C]-KBP-5074 | EXPERIMENTAL | - |
| Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074) | EXPERIMENTAL | - |
| Cohort 2 (Effects of CYP3A4 induction on KBP-5074) | EXPERIMENTAL | - |
| KBP-5074 Capsule | ACTIVE_COMPARATOR | KBP-5074 capsule, 0.5 mg or 1.0 mg, QD, single dose |
| KBP-5074 Tablet | EXPERIMENTAL | KBP-5074 tablet, 0.5 mg or 1.0 mg, QD, single dose |
| KBP-5074 | EXPERIMENTAL | Single oral dose |
| KBP-5074: Cohort 1 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 2 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 3 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 4 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 5 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Fed Group | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| Name | Type | Description |
|---|---|---|
| KBP-5074 0.25 mg tablet | DRUG | Oral administration, QD, 84 days |
| KBP-5074 0.5 mg tablet | DRUG | Oral administration, QD, 84 days |
| KBP-5074 | DRUG | - |
| Itraconazole | DRUG | 200 mg itraconazole, given orally as 20 mL × 10-mg/mL solution BID on Day 15, followed by QD dosing on Days 16 through 23, inclusive. |
| Rifampin | DRUG | 600 mg rifampin, given orally as 2 × 300-mg capsules QD on Days 15 through 25, inclusive. |
| KBP-5074 Capsule | DRUG | KBP-5074 (0.5 mg or 1.0 mg) capsule formulation single dose, in a 2-period crossover design with a 2-week washout/follow-up period |
| KBP-5074 Tablet | DRUG | KBP-5074 (0.5 mg or 1.0 mg) tablet formulation single dose, in a 2-period crossover design with a 2-week washout/follow-up period |
Inclusion Criteria: 1. Male or female, between 18 and 85 years of age, inclusive. The lower age limit may be higher if it is legally required in the participating country; 2. Body mass index between 19 and 45 kg/m2, inclusive; 3. Stage 3B/4 CKD (defined as eGFR 15 and 44 mL/min/1.73 m2, based on th...
KBP-5074 is an investigational small molecule being studied for chronic kidney disease and related conditions, including renal impairment. It is also being evaluated in healthy volunteers for bioequivalence and drug interaction studies. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
KBP-5074 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.
KBP-5074 is in Phase 1 clinical development. All four clinical trials for the drug have been completed, with a total enrollment of 162 participants. The drug remains investigational and has not received FDA approval.
KBP-5074 has been studied in four completed Phase 1 trials. These include NCT02228733, a single ascending dose study in healthy volunteers; NCT02653014, a study in healthy subjects and those with renal impairment; NCT04606537, a drug-drug interaction study; and NCT04634812, a mass balance study in healthy males.
KBP-5074 is the primary name used for this investigational drug in clinical trials. No alternative names have been associated with it in the available clinical trial records. Researchers and investors should refer to it as KBP-5074 when searching for related study information.