Healthy VolunteersPhase 1NCT04793204
A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
A Phase 1 study testing fezolinetant in people with Healthy Volunteers, run by Astellas Pharma China, Inc. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and safety of fezolinetant after single-dose and multiple dose administration in healthy Chinese female participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- fezolinetant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2021to 21 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 other obvious pathological or physiological cause) prior to screening, or documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
- Or, if of childbearing potential, agree not to try to become pregnant during the study and for 30 days after the final study drug administration; and have a negative pregnancy test at screening and day -1; and if heterosexually active, agree to consistently use 1 form of effective birth control starting at screening and throughout the study period and for 30 days after the final study drug administration. If male partner has undergone effective surgical sterilization (vasectomy or bilateral orchiectomy), it is not necessary to implement the birth control method.
- Subject must agree not to breastfeed starting at screening and throughout the study period, and for 30 days after the final study drug administration.
- Subject must not donate ova starting at screening and throughout the study period, and for 30 days after the final study drug administration.
- Subject agrees not to participate in another interventional study while participating in the present study, defined as 84 days prior to the screening test until completion of the last study visit.
Who cannot join
- Subject has been pregnant within 6 months (including delivery or abortion) or has been breast feeding within 3 months prior to the screening test.
- Subject has had previous exposure with fezolinetant.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study drug administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] and total bilirubin [TBL]) above the upper limit of normal at screening or day -1. In such a case, the assessment is allowed to repeated only once.
Show all 25Show fewer
- Subject applies to any of the following concerns with regard to tuberculosis.
- History of active tuberculosis
- Significant abnormalities detected in a chest X-ray test at Screening
- Contact with infectious tuberculous patients
- Subject had clinically significant abnormality in their laboratory value at screening test and on day -1.
- Subject who deviated from the following range of vital signs or routine 12-lead electrocardiogram (ECG) results at screening test or day -1. If QT interval corrected by Fridericia method (QTcF) exceeds the limits determined, ECG is allowed to be repeated once; if pulse rate or ear temperature exceeds the limits determined, the measurements of pulse and ear temperature are allowed to be repeated once; if the blood pressure exceed limits determined, the measurement of blood pressure should be repeated once. The final judgment should be based on the retest results.
- Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody, hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibody, syphilis and hepatitis A virus (HAV) antibodies (immunoglobulin M [IgM]) at screening.
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, tricyclic antidepressants, phencyclidine, cocaine and opiates) within 3 months prior to day -1. Subject who has a history of drug abuse within 2 years prior to screening test.
- Subject has used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives, hormone replacement therapy [HRT], natural and herbal remedies, e.g. St. John's Wort, Chinese medicine such as Heyan Kuntai Capsule) in 3 months prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day) and topical dermatological products, including corticosteroid products.
- Subject has used any inducer of metabolism (e.g. barbiturates, rifampin) in 3 months prior to day -1.
- Subject has a history of smoking within 3 months prior to day -1.
- Subject whose daily caffeine consumption is ≥ 500 mg (500 mg of caffeine: about 800 mL of coffee, 1600 mL of black tea, 2500 mL of green tea, 5000 mL of cola).
- Subject whose weekly alcohol consumption is ≥14 units* within 6 months prior to screening test, or who has a history of alcohol dependency, drug dependency, chemical dependency, or alcohol abuse within 2 years prior to screening test (*1 unit: approximately 360 mL of beer, 120 mL of wine, 30 mL of spirit).
- Subject who has had blood sampled or donated blood during the following period.
- Whole blood sample of ≥ 400 mL: from 90 days prior to screening test until hospital admission.
- Whole blood sample of ≥ 200 mL: from 30 days prior to screening test until hospital admission.
- Blood component donation: from 14 days prior to screening test until hospital admission.
- Subject is employed by the sponsor, contract research organization (CRO), or study center associated with this study.
- Subject is deemed unsuitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of Fezolinetant - An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
The purpose of this study is to evaluate the pharmacokinetics and safety of fezolinetant after single-dose and multiple dose administration in healthy Chinese female participants.
Read the detailed description
Participants will undergo screening evaluations to determine their eligibility within 21 days prior to the study enrollment.
Participants will be admitted to the clinical unit a day before administration (day -1) and will be confined in the clinical unit until 48 hours after last administration (day 18).
- Conditions
- Healthy Volunteers
- Being tested
- fezolinetant
- Keywords
- Fezolinetant, Pharmacokinetics, ESN364, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fezolinetantDrug
Also called ESN364
oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: fezolinetant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
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.
Measured: Up to day 41
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Measured: Up to day 41
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Measured: Up to day 41
Number of participants with rountine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Measured: Up to day 41
Pharmacokinetics (PK) of fezolinetant in plasma: AUC24
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.
Measured: Up to day 7
Pharmacokinetics (PK) of fezolinetant in plasma: AUCinf
AUC from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 7
Pharmacokinetics (PK) of fezolinetant in plasma: AUCinf(%extrap)
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 7
Pharmacokinetics (PK) of fezolinetant in plasma: AUClast
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.
Measured: Up to day 7
Pharmacokinetics (PK) of fezolinetant in plasma: Ctrough
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: AUCtau
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.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: CL/F
Apparent total clearance after extra-vascular dosing (CL/F) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: Cmax
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: PTR
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: Rac(AUC)
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: Rac(Cmax)
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: t1/2
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: tmax
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: Vz/F
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.
Measured: Up to day 16
Pharmacokinetics (PK) of fezolinetant in plasma: Tlag
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: AUC24
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.
Measured: Up to day 7
Pharmacokinetics (PK) of ES259564 in plasma: AUCinf
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.
Measured: Up to day 7
Pharmacokinetics (PK) of ES259564 in plasma: AUCinf(%extrap)
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 7
Pharmacokinetics (PK) of ES259564 in plasma: AUClast
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.
Measured: Up to day 7
Pharmacokinetics (PK) of ES259564 in plasma: Ctrough
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: AUCtau
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.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: Cmax
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: PTR
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: Rac(AUC)
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: Rac(Cmax)
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: t1/2
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: tmax
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: MPR
Metabolite to parent ratio (MPR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Pharmacokinetics (PK) of ES259564 in plasma: Tlag
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start24 Mar 2021
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793204
- Sponsor's protocol ID
- 2693-CL-0030
- Status last verified
- Oct 2024
- First submitted
- 9 Mar 2021
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Fezolinetant - An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
- ClinicalTrials.gov ID
- NCT04793204
- Acronym / sponsor ID
- 2693-CL-0030
- Conditions
- Healthy Volunteers
- Keywords
- Fezolinetant, Pharmacokinetics, ESN364, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics and safety of fezolinetant after single-dose and multiple dose administration in healthy Chinese female participants.
Detailed description
Participants will undergo screening evaluations to determine their eligibility within 21 days prior to the study enrollment.
Participants will be admitted to the clinical unit a day before administration (day -1) and will be confined in the clinical unit until 48 hours after last administration (day 18).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fezolinetant | Experimental | Drug: fezolinetantA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Subject must agree not to breastfeed starting at screening and throughout the study period, and for 30 days after the final study drug administration.
- Subject must not donate ova starting at screening and throughout the study period, and for 30 days after the final study drug administration.
Key exclusion criteria (25 listed)
- Subject has been pregnant within 6 months (including delivery or abortion) or has been breast feeding within 3 months prior to the screening test.
- Subject has had previous exposure with fezolinetant.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study drug administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fezolinetantAlso: ESN364oral | Drug | fezolinetant |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to day 41
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 laboratory value abnormalities and/or adverse events (AEs)
Time frame: Up to day 41
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time frame: Up to day 41
Number of participants with potentially clinically significant vital sign values.
Number of participants with rountine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Time frame: Up to day 41
Number of participants with potentially clinically significant ECG values.
Pharmacokinetics (PK) of fezolinetant in plasma: AUC24
Time frame: Up to day 7
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.
Pharmacokinetics (PK) of fezolinetant in plasma: AUCinf
Time frame: Up to day 7
AUC from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: AUCinf(%extrap)
Time frame: Up to day 7
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: AUClast
Time frame: Up to day 7
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.
Pharmacokinetics (PK) of fezolinetant in plasma: Ctrough
Time frame: Up to day 16
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: AUCtau
Time frame: Up to day 16
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.
Pharmacokinetics (PK) of fezolinetant in plasma: CL/F
Time frame: Up to day 16
Apparent total clearance after extra-vascular dosing (CL/F) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: Cmax
Time frame: Up to day 16
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: PTR
Time frame: Up to day 16
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: Rac(AUC)
Time frame: Up to day 16
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: Rac(Cmax)
Time frame: Up to day 16
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: t1/2
Time frame: Up to day 16
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: tmax
Time frame: Up to day 16
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of fezolinetant in plasma: Vz/F
Time frame: Up to day 16
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.
Pharmacokinetics (PK) of fezolinetant in plasma: Tlag
Time frame: Up to day 16
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: AUC24
Time frame: Up to day 7
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.
Pharmacokinetics (PK) of ES259564 in plasma: AUCinf
Time frame: Up to day 7
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.
Pharmacokinetics (PK) of ES259564 in plasma: AUCinf(%extrap)
Time frame: Up to day 7
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: AUClast
Time frame: Up to day 7
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.
Pharmacokinetics (PK) of ES259564 in plasma: Ctrough
Time frame: Up to day 16
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: AUCtau
Time frame: Up to day 16
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.
Pharmacokinetics (PK) of ES259564 in plasma: Cmax
Time frame: Up to day 16
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: PTR
Time frame: Up to day 16
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: Rac(AUC)
Time frame: Up to day 16
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: Rac(Cmax)
Time frame: Up to day 16
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: t1/2
Time frame: Up to day 16
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: tmax
Time frame: Up to day 16
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: MPR
Time frame: Up to day 16
Metabolite to parent ratio (MPR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ES259564 in plasma: Tlag
Time frame: Up to day 16
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma China, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fezolinetant in people with Healthy Volunteers, run by Astellas Pharma China, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: Up to day 41). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.