Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Febuxostat F1 · 1 trial · 1 indication
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.
AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence ABDC | EXPERIMENTAL | Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C). |
| Treatment Sequence DACB | EXPERIMENTAL | Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B). |
| Treatment Sequence CDBA | EXPERIMENTAL | Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A). |
| Treatment Sequence BCAD | EXPERIMENTAL | Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D). |
| Name | Type | Description |
|---|---|---|
| Febuxostat XR 80 mg Capsule F1 | DRUG | Febuxostat extended-release (XR) capsules formulation 1 |
| Febuxostat XR 80 mg Capsule F2 | DRUG | Febuxostat XR capsules formulation 2 |
| Febuxostat XR 80 mg Capsule F3 | DRUG | Febuxostat XR capsules formulation 3 |
| Febuxostat XR 80 mg Capsule F4 | DRUG | Febuxostat XR capsules formulation 4 |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
Febuxostat F1 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It is an extended-release capsule formulation containing 80 mg of febuxostat, studied in healthy adult volunteers. The specific therapeutic indication for this formulation has not been disclosed.
Febuxostat F1 targets xanthine dehydrogenase (XDH). It acts as an inhibitor of this enzyme. XDH inhibition is the established mechanism of the febuxostat molecule, and this extended-release formulation was designed to deliver the same active agent.
Febuxostat F1 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 relative bioavailability study of this extended-release 80 mg capsule formulation.
Febuxostat F1 is in Phase 1 clinical development. It is an investigational formulation and has not been approved by the FDA. The single Phase 1 trial has been completed, and no active trials are currently listed.
Febuxostat F1 was evaluated in one completed Phase 1 trial, NCT02504320, titled Phase 1, Febuxostat XR Relative Bioavailability Study. The trial enrolled 78 healthy adult volunteers in the United States, used a controlled and randomized design, and included both male and female participants aged 18 years and older.