Healthy VolunteersPhase 1NCT04476849
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
A Phase 1 study testing fezolinetant in people with Healthy Volunteers and Renal Impairment, run by Astellas Pharma Global Development, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Renal Impairment
- 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
- 27 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Aug 2020to 11 Mar 2022
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has a Body Mass Index (BMI) range of 18.5 to 40 kg/m^2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least one of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance for at least 30 days prior to day -1 through at least 30 days after final IP administration
- Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
- Female subject must not donate ova starting from administration of IP and throughout the study period and for 30 days after final IP administration.
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- Subject has normal renal function as defined by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula ≥ 90 milliliters per minute (mL/min) per 1.73 m^2 or subject has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and by eGFR:
- 60 to < 90 mL/min per 1.73 m^2 for subject with mild renal impairment
- 30 to < 60 mL/min per 1.73 m^2 for subject with moderate renal impairment
- < 30 mL/min per 1.73 m^2 and not on hemodialysis for subject with severe renal impairment
- Subject has adequate venous access.
- Subject agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Subject has received any investigational therapy within 28 days or five half-lives, whichever is longer, prior to Day -1.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within six months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used.
- Subject has had previous exposure with fezolinetant.
- Subject has any of the liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin [TBL]) ≥ 1.5 × the Upper Limit of Normal (ULN) on Day -1. In such a case, the assessment may be repeated once.
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- 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 IP administration.
- 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 smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within six months prior to screening or the subject tests positive for cotinine at screening or on Day -1.
- Subject has a history of consuming > 7 units of alcoholic beverages per week within six months prior to screening or has a history of alcoholism three months prior to screening or drug/chemical/ substance abuse within one year prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol at screening or on Day -1.
- Subject has used any inducer of cytochrome P450 (CYP) 1A2 in the three months prior or inhibitors of CYP 1A2 in the two weeks or five half-lives, whichever is longer, prior to Day -1.
- Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within seven days prior to Day -1 and/or received a transfusion of any blood or blood products within 60 days.
- Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
- Subject is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
- Additional criteria for subjects with renal impairment:
- Subject who has a history of any clinically significant illness (other than renal disease and conditions related to renal disease, such as stable diabetes and stable hypertension), medical condition or laboratory abnormality within 3 months prior to screening which precludes the subject from study participation.
- Subject has a mean pulse < 40 or > 90 beats per minutes (bpm); mean systolic blood pressure (SBP) < 90 or > 160 millimeters of mercury (mmHg); mean diastolic blood pressure (DBP) < 50 or > 100 mmHg (measurements taken in triplicate after subject has been resting in the supine position for at least five minutes; pulse will be measured automatically) on Day -1. If the mean blood pressure exceeds the limits above, one additional triplicate may be taken.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of > 480 msec on Day -1. If the mean QTcF exceeds the limits above, one additional triplicate ECG may be taken.
- Subject who has had a change in dose regimen of medically required medication(s) in the two weeks prior to IP administration (permitted concomitant medications) and/or subject for whom dose changes are likely to occur during the study (minor dose changes are allowed in agreement with the sponsor) and/or subject has used nonpermitted concomitant medication(s) (including vitamins, hormonal contraceptives, hormone replacement therapy [HRT] and natural and herbal remedies, e.g., St. John's Wort) in the three weeks prior to admission to the clinical unit.
- Subject who requires or is likely to require any new concomitant medications during the course of the study.
- Subject who has a renal disease secondary to malignancy.
- Subject who has a fluctuating or rapidly deteriorating renal function within four weeks prior to IP administration, as indicated by strongly varying or worsening clinical and/or laboratory signs of renal impairment within the screening period.
- Subject has a hemoglobin result of < 9 grams per deciliter.
- Subject has a functioning kidney transplant.
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within three months prior to Day -1 or the subject tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on Day -1, unless the positive result is due to an approved prescription medication.
- Additional criteria for healthy subjects with normal renal function:
- 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 any clinically significant abnormality following the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on Day -1.
- Subject has a mean pulse < 45 or > 90 bpm; mean SBP > 150 mmHg; mean DBP > 90 mmHg (measurements taken in triplicate after subject has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on Day -1. If the mean blood pressure exceeds the limits above, one additional triplicate may be taken.
- Subject has a mean QTcF of > 450 msec on Day -1. If the mean QTcF exceeds the limits above, one additional triplicate ECG may be taken.
- Subject has used any prescribed or nonprescribed drugs (including vitamins, hormonal contraceptives, HRT and natural and herbal remedies, e.g., St. John's Wort) in the two weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day).
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within three months prior to Day -1 or the subject tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on Day -1.
- Subject has creatinine level outside normal limits on Day -1. In such a case, the assessment may be repeated once.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720
National Institute of Clinical Research
Garden Grove, California, 92844
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, 32809
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
Prism research, LLC
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1 Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Renal Function
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function.
This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function.
Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73 m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment, severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal (eGFR ≥ 90 mL/min per 1.73 m^2) renal function.
Read the detailed description
This study will be comprised of four groups of participants based on renal function. Participants will be screened for up to 28 days prior to investigational product (IP) administration on Day 1. Eligible participants with mild, moderate and severe renal function and healthy participants with normal renal function will be admitted to the clinical unit on Day -1 and will be residential for a single period of six days/five nights. On Day 1, participants will receive a single oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and urine sampling period. Participants are to remain awake, seated or semirecumbent and avoid lying on either the left or right side for at least four hours postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on Day 5 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit.
The study will be completed with an end-of-study visit (ESV). The ESV will take place five to nine days after the last pharmacokinetic sample is collected or at early discontinuation from the study.
- Conditions
- Healthy Volunteers, Renal Impairment
- Being tested
- fezolinetant
- Keywords
- Healthy volunteers, Pharmacokinetics, ES259564, Renal impairment, fezolinetant
- Medical subject headings
- Renal Insufficiency
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: Mild renal impairment | Experimental | Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. Receives: Drug: fezolinetant |
| Fezolinetant: Moderate renal impairment | Experimental | Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. Receives: Drug: fezolinetant |
| Fezolinetant: Severe renal impairment | Experimental | Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. Receives: Drug: fezolinetant |
| Fezolinetant: Normal renal function | Experimental | Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. Receives: Drug: fezolinetant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of Fezolinetant in Plasma: Area Under the Concentration-time Curve (AUC) From the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
PK of Fezolinetant in Plasma: AUC From the Time of Dosing to the Last Measurable Concentration (AUClast)
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
PK of Fezolinetant in Plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
PK of Fezolinetant in Plasma: Apparent Clearance (CL/F)
CL/F will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
PK of Fezolinetant Metabolite ES259564 in Plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
PK of Fezolinetant Metabolite ES259564 in Plasma: AUClast
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
PK of Fezolinetant Metabolite ES259564 in Plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 5 days
Secondary outcomes (4)
Number of Participants With Adverse Events (AEs)
AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an IP and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 days
Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 14 days
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 14 days
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant 12-ECG values.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start10 Aug 2020
- Primary completion6 Mar 2022
- Study completion11 Mar 2022
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.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476849
- Sponsor's protocol ID
- 2693-CL-0008
- Status last verified
- Oct 2024
- First submitted
- 15 Jul 2020
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT04476849
- Acronym / sponsor ID
- 2693-CL-0008
- Conditions
- Healthy Volunteers, Renal Impairment
- Keywords
- Healthy volunteers, Pharmacokinetics, ES259564, Renal impairment, fezolinetant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 20 Jul 2020 (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 of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function.
This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function.
Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73 m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment, severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal (eGFR ≥ 90 mL/min per 1.73 m^2) renal function.
Detailed description
This study will be comprised of four groups of participants based on renal function. Participants will be screened for up to 28 days prior to investigational product (IP) administration on Day 1. Eligible participants with mild, moderate and severe renal function and healthy participants with normal renal function will be admitted to the clinical unit on Day -1 and will be residential for a single period of six days/five nights. On Day 1, participants will receive a single oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and urine sampling period. Participants are to remain awake, seated or semirecumbent and avoid lying on either the left or right side for at least four hours postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on Day 5 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit.
The study will be completed with an end-of-study visit (ESV). The ESV will take place five to nine days after the last pharmacokinetic sample is collected or at early discontinuation from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fezolinetant: Mild renal impairment | Experimental | Drug: fezolinetantParticipants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. |
| Fezolinetant: Moderate renal impairment | Experimental | Drug: fezolinetantParticipants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. |
| Fezolinetant: Severe renal impairment | Experimental | Drug: fezolinetantParticipants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. |
| Fezolinetant: Normal renal function | Experimental | Drug: fezolinetantParticipants will receive a single oral dose of fezolinetant under fasting conditions on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has a Body Mass Index (BMI) range of 18.5 to 40 kg/m^2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least one of the following conditions apply:
- Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
- Female subject must not donate ova starting from administration of IP and throughout the study period and for 30 days after final IP administration.
- Subject has normal renal function as defined by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula ≥ 90 milliliters per minute (mL/min) per 1.73 m^2 or subject has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and by eGFR:
Key exclusion criteria (33 listed)
- Subject has received any investigational therapy within 28 days or five half-lives, whichever is longer, prior to Day -1.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within six months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used.
- Subject has had previous exposure with fezolinetant.
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: Mild renal impairment, Fezolinetant: Moderate renal impairment, Fezolinetant: Normal renal function, Fezolinetant: Severe renal impairment |
Primary outcome
Pharmacokinetics (PK) of Fezolinetant in Plasma: Area Under the Concentration-time Curve (AUC) From the Time of Dosing Extrapolated to Time Infinity (AUCinf)
Time frame: Up to 5 days
AUCinf will be recorded from the PK plasma samples collected.
PK of Fezolinetant in Plasma: AUC From the Time of Dosing to the Last Measurable Concentration (AUClast)
Time frame: Up to 5 days
AUClast will be recorded from the PK plasma samples collected.
PK of Fezolinetant in Plasma: Maximum Concentration (Cmax)
Time frame: Up to 5 days
Cmax will be recorded from the PK plasma samples collected.
PK of Fezolinetant in Plasma: Apparent Clearance (CL/F)
Time frame: Up to 5 days
CL/F will be recorded from the PK plasma samples collected.
PK of Fezolinetant Metabolite ES259564 in Plasma: AUCinf
Time frame: Up to 5 days
AUCinf will be recorded from the PK plasma samples collected.
PK of Fezolinetant Metabolite ES259564 in Plasma: AUClast
Time frame: Up to 5 days
AUClast will be recorded from the PK plasma samples collected.
PK of Fezolinetant Metabolite ES259564 in Plasma: Cmax
Time frame: Up to 5 days
Cmax will be recorded from the PK plasma samples collected.
4 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to 14 days
Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
Time frame: Up to 14 days
Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)
Time frame: Up to 14 days
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
Time frame: Up to 14 days
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 17 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.
Executive Medical Director study director
Astellas Pharma Global Development, Inc.
7 sites 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 and Renal Impairment, run by Astellas Pharma Global Development, Inc. at 7 sites in United States.
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 12 inclusion and 33 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 17 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 7 sites in United States. 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?
Pharmacokinetics (PK) of Fezolinetant in Plasma: Area Under the Concentration-time Curve (AUC) From the Time of Dosing Extrapolated to Time Infinity (AUCinf) (time frame: Up to 5 days). The study lists 7 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 17 Oct 2024.