Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fezolinetant · 1 trial · 1 indication
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with potentially clinically significant laboratory values.
Number of participants with potentially clinically significant vital sign values.
Number of participants with potentially clinically significant ECG values.
Area under the concentration-time curve from the time of dosing to 24 hours (AUC24) will be recorded from the pharmacokinetic (PK) plasma samples collected.
AUC from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
AUC from the time of dosing to the start of the next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Apparent total clearance after extra-vascular dosing (CL/F) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Apparent volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration-time curve from the time of dosing to 24 hours (AUC24) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
AUC from the time of dosing to the start of the next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Metabolite to parent ratio (MPR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
| Arm | Type | Description |
|---|---|---|
| fezolinetant | EXPERIMENTAL | A single oral dose of fezolinetant will be administered with water under fasting conditions on day 1 (low dose), day 4 (medium dose) and day 7 (high dose). From day 10 to day 15, the medium dose of fezolinetant will be administered with water after breakfast once daily. On day 16, the medium dose of fezolinetant will be administered with water under fasting conditions. |
| Name | Type | Description |
|---|---|---|
| fezolinetant | DRUG | oral |
Inclusion Criteria: * Subject has a body mass index (BMI) range of \> 19 kg/m\^2 and ≤ 24.9 kg/m\^2. * Subject has a body weight at screening ≥ 45.0 kg. * Subject must either: * Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year without any menses for which there is no o...
Fezolinetant is an investigational small molecule being studied in healthy volunteers. It is not approved for any condition and remains in clinical development. The only completed trial evaluated its pharmacokinetics and safety in healthy Chinese female subjects.
Fezolinetant is being developed by China Pharma Holdings, Inc., which trades under the ticker CPHI. The company is conducting clinical research on this investigational small molecule.
Fezolinetant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed.
Fezolinetant has one completed clinical trial, NCT04793204, titled "A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects." This Phase 1 study enrolled 16 participants in China.
Fezolinetant is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, meaning it has not been authorized for commercial use.