Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-272 · 2 trials · 3 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.
| 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 |
| 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 |
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 developed by Takeda Pharmaceutical Company Limited. It has been studied in clinical trials for renal impairment, type 2 diabetes mellitus, and microalbuminuria. TAK-272 remains in clinical development and is not approved for any indication.
TAK-272 has been evaluated in a Phase 2 dose-finding study for participants with type 2 diabetes mellitus and microalbuminuria. The trial, NCT02332824, enrolled 415 participants in Japan and has been completed. TAK-272 is investigational and has not been approved for treating these conditions.
TAK-272 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical studies of TAK-272, including a Phase 1 pharmacokinetics trial and a Phase 2 dose-finding trial conducted in Japan.
TAK-272 is in Phase 1 development. A Phase 2 dose-finding study in type 2 diabetes mellitus and microalbuminuria has also been completed, but the asset is not FDA approved and remains investigational. No active trials of TAK-272 are currently listed.
TAK-272 has been studied in two completed trials. NCT02367872 was a Phase 1 open-label pharmacokinetics study in participants with renal or hepatic impairment, enrolling 48 people in Japan. NCT02332824 was a Phase 2 dose-finding study in type 2 diabetes mellitus and microalbuminuria, enrolling 415 participants in Japan.