Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ASP1517 · 3 trials · 2 indications
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
AUC24h: Area under the concentration-time curve from the time of dosing to 24h
Cmax: Maximum concentration
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Cmax: Maximum concentration
| Arm | Type | Description |
|---|---|---|
| ASP1517 alone period preceding group | EXPERIMENTAL | Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. |
| ASP1517+lanthanum period preceding group | EXPERIMENTAL | Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2. |
| ASP1517 fasting then fed | EXPERIMENTAL | Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2. |
| ASP1517 fed then fasting | EXPERIMENTAL | Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2. |
| Group 1 | EXPERIMENTAL | Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) |
| Group 2 | EXPERIMENTAL | Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration) |
| Name | Type | Description |
|---|---|---|
| ASP1517 | DRUG | Oral dose |
| Lanthanum carbonate hydrate | DRUG | Oral dose |
| Kremezin® | DRUG | Oral |
Inclusion Criteria: * Body weight (at screening): ≥50.0 kg and \<80.0 kg * Body-mass index (at screening): ≥17.6 and \<26.4 kg/m2 \[Body-mass index = Body weight (kg)/(Height (m))2\] * Subject must agree to use contraception consisting of two established forms specified below starting at the time o...
ASP1517 is an investigational small molecule being studied in healthy volunteers and healthy subjects. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics, including food effects and drug interactions. ASP1517 is not approved for any indication and remains under investigation.
ASP1517 is being developed by Kyntra Bio, Inc., a biopharmaceutical company. The company's stock ticker is KYNB. Kyntra Bio is conducting Phase 1 clinical trials to evaluate the pharmacokinetics of ASP1517 in healthy subjects.
ASP1517 is in Phase 1 clinical development. All three of its clinical trials are completed, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
ASP1517 has completed three Phase 1 trials: NCT02693613, a pharmacokinetic study with Kremezin in healthy volunteers; NCT02805374, a food effect study in healthy subjects; and NCT02952040, a drug interaction study with lanthanum carbonate hydrate in healthy subjects. All trials were conducted in Japan.
ASP1517 is also known as roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor. In clinical trials, it has been studied under the name ASP1517 for its pharmacokinetic properties in healthy subjects. The drug is being developed by Kyntra Bio, Inc.