Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-272 · 3 trials · 4 indications
The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR.
AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272.
Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.
AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272.
CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272.
Urinary excretion ratio (percentage \[%\] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant.
Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein.
Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant.
Number of participants who had ECG findings changed from "within normal limit" or "abnormal, clinically significant" to "abnormal and clinically significant" after study drug administration.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 5 mg | EXPERIMENTAL | TAK-272 5 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 20 mg | EXPERIMENTAL | TAK-272 20 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 40 mg | EXPERIMENTAL | TAK-272 20 mg 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 80 mg | EXPERIMENTAL | TAK-272 20 mg 4 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| Candesartan cilexetil 8 mg | ACTIVE_COMPARATOR | TAK-272 placebo 4 tablets and Candesartan cilexetil 8 mg one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| Participants with normal renal function: TAK-272 40 mg | ACTIVE_COMPARATOR | Fasted single oral administration of TAK-272 40 milligram (mg) |
| Participants with mild renal impairment: TAK-272 40 mg | EXPERIMENTAL | Fasted single oral administration of TAK-272 40 mg |
| Participants with moderate renal impairment: TAK-272 40 mg | EXPERIMENTAL | Fasted single oral administration of TAK-272 40 mg |
| Participants with severe renal impairment: TAK-272 40 mg | EXPERIMENTAL | Fasted single oral administration of TAK-272 40 mg |
| Hemodialysis participants: TAK-272 40 mg | EXPERIMENTAL | Fasted single oral administration of TAK-272 40 mg |
| Participants with normal hepatic function: TAK-272 40 mg | ACTIVE_COMPARATOR | Fasted single oral administration of TAK-272 40 mg |
| Participants with mild hepatic impairment: TAK-272 40 mg | EXPERIMENTAL | Fasted single oral administration of TAK-272 40 mg |
| Participants with moderate hepatic impairment: TAK-272 40 mg | EXPERIMENTAL | Fasted single oral administration of TAK-272 40 mg |
| Cohort 1: TAK-272 + Itraconazole | EXPERIMENTAL | TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12. |
| Cohort 2: Midazolam + Digoxin + TAK-272 | EXPERIMENTAL | Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8. |
| Name | Type | Description |
|---|---|---|
| TAK-272 | DRUG | TAK-272 tablets |
| TAK-272 Placebo | DRUG | TAK-272 placebo-matching tablets |
| Candesartan cilexetil | DRUG | Candesartan cilexetil tablets |
| Candesartan cilexetil Placebo | DRUG | Candesartan cilexetil placebo-matching tablets |
| Digoxin | DRUG | Digoxin tablet. |
| Itraconazole | DRUG | Itraconazole oral solution |
| Midazolam | DRUG | Midazolam syrup. |
Inclusion Criteria: * In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements. * The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. * The participa...
TAK-272 is an investigational small molecule being studied for use in Type 2 Diabetes Mellitus with microalbuminuria, as well as in renal impairment, hepatic impairment, and in Japanese healthy adult males for pharmacokinetic and drug interaction studies. It is developed by Takeda Pharmaceutical Company Limited.
TAK-272 is being developed by Takeda Pharmaceutical Company Limited, whose stock trades under the ticker TAK. The company has conducted clinical trials of TAK-272 in Japan across multiple indications.
TAK-272 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial was a dose-finding study in participants with Type 2 Diabetes Mellitus and microalbuminuria, while Phase 1 trials evaluated pharmacokinetics and drug interactions. TAK-272 remains investigational and is not approved.
TAK-272 has been studied in three completed trials in Japan. NCT02332824 was a Phase 2 dose-finding study in Type 2 Diabetes Mellitus with microalbuminuria. NCT02367872 was a Phase 1 pharmacokinetic study in renal or hepatic impairment. NCT02370615 was a Phase 1 drug-drug interaction study in healthy Japanese males.
TAK-272 is the code name used by Takeda for this investigational compound. No alternative names are available in the clinical trial records, so it is referred to solely as TAK-272 in the studies conducted.