Healthy VolunteersPhase 1NCT04143477
A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects
A Phase 1 study testing peficitinib 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 ASP015K after single-dose and multiple-dose administration in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- peficitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2019to 21 Dec 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal Body Mass index (BMI) and weight: BMI[= weight kg/(height m)^2] > 19 kg/m^2 and ≤ 24 kg/m^2, the weight is no less than 50 kg for male and 45 kg for female at screening.
- Female subject must either: Be of non-childbearing potential, postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile. Or, if of childbearing potential: agree not to try to become pregnant during the study and for 60 days after the final study drug administration, must have a negative pregnancy at Screening and Day -1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
- Female subject must not donate ova starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
- Male subject and female spouse/partners who are of childbearing potential must be using 1 form of highly effective birth control starting at Screening and throughout the study period, and for 90 days after the final study drug administration.
- Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration.
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit.
Who cannot join
- Female subject who has been pregnant within 6 months prior to screening or breast feeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
- Subject has any of the liver chemistry tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] and total bilirubin [TBL]) above the upper limit of normal on Day -1. In such a case, the assessment may be repeated once.
- Subjects who meet any of the following criterion for laboratory tests on Day -1. Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study. In such a case, the assessment may be repeated once.
- Hematology: a deviation of +20% from the upper limit or -20% from the lower limit of the normal range, and clinically significant.
- Blood biochemistry: a deviation from the normal range regarding serum creatinine, serum electrolytes (Na, K, and Cl), or fasting blood glucose; a deviation of +20% from the upper limit or -20% from the lower limit of the normal range regarding laboratory test items other than above, and clinically significant. However, the lower limit of the normal range will not be established for lactate dehydrogenase (LD), creatinine kinase (CK), total cholesterol, triglyceride, urea, serum creatinine, and uric acid, whose deviation from the lower limit is considered not clinically significant.
Show all 38Show fewer
- Urinalysis: a deviation from the normal range of each urinalysis test item.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, respiratory,pulmonary, neurologic, cerebrovascular, lymphatic, 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 clinically significant abnormality in the physical examination, 12-lead electrocardiogram (ECG) and protocol defined clinical laboratory tests at Screening or Day -1.
- Subject has a pulse rate < 45 or > 100 bpm; systolic blood pressure (SBP) > 140 mmHg; diastolic blood pressure (DBP) > 90 mmHg (measurements taken after subject has been resting in sit position for 5 min; pulse will be measured automatically) at screening or on Day -1. If the pulse rate or blood pressure exceeds the limits above, 1 additional test can be taken.
- Subjects with abnormal body temperature, defined as axillary temperature >37.3 ºC or <35.0 ºC at Screening or Day -1.
- Subject has a corrected QT interval (QTcF) of > 430 ms (for males) and > 450 ms (for females) at screen or on Day -1(at screen and on Day-1, will be performed). If the QTcF exceeds the limits above on Day-1, 1 additional ECG test can be taken.
- Subject has any history or evidence of congenital short QT syndrome(defined as QTc < 330 ms).
- Subject has any history of gastrointestinal resection (excepted appendectomy)..
- Subject has developed upper gastrointestinal symptoms within 1 week prior to Day -1.
- Subject applies to any of the following concerns with regard to tuberculosis.
- History of active tuberculosis
- Abnormalities detected in a chest X-ray test at Screening
- Contact with infectious tuberculous patients
- T-spot or Quantiferon Gold test show tuberculosisinfection positive.
- Subject applies to any of the following concerns with regard to infection other than tuberculosis.
- Complication or history of severe herpes zoster or herpes zoster disseminated.
- At least twice of relapse of localized herpes zoster
- Inpatient hospital care for severe infectious diseases within 90 days prior to Day -1
- Treatment with intravenous antibiotics within 90 days prior to Day -1 (prophylactic antibiotics are not applicable).
- Other than above, with a high risk of developing infectious disease (subjects with urethral catheterisation etc.).
- Subject has vaccination of live vaccines or live attenuated vaccines within 56 days prior to Day -1 (inactivated vaccines such as influenza vaccine and pneumococcal vaccines are not applicable.).
- Subject has used any prescribed or nonprescribed drugs (including vitamins or natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 14units of alcohol for female subjects) within 3 months prior to admission to the clinical unit or the subject tests positive for alcohol or drugs of abuse at Screening or Day -1 (amphetamines,barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
- Subject has used any drugs of abuse within 3 months prior to admission to the clinical unit.
- Subject has had significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to Day -1.
- Subject has a positive serology test for hepatitis B surface antigen (HBsAg), antihepatitis A virus (immunodeficiency virus [Ig]M), anti-hepatitis C virus, anti-hepatitis B core or antihuman immunodeficiency virus (HIV) at Screening.
- Subject has participated in any clinical study or has been treated with any investigational drugs within 3 moths prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Subject is an employee of the Astellas Group, Clinical Research Organization (CRO) or the clinical unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics and safety of ASP015K after single-dose and multiple-dose administration in healthy Chinese participants.
- Conditions
- Healthy Volunteers
- Being tested
- peficitinib
- Keywords
- peficitinib, ASP015K, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peficitinibDrug
Also called ASP015K
Oral
| Study group | Role | What they receive |
|---|---|---|
| Peficitinib 50 mg | Experimental | Participants will receive a single dose of 50 milligrams (mg) under fasted condition Day 1, followed by multiple doses of 50 mg under fed condition once daily in the morning from Day 8 till Day 13. Receives: Drug: peficitinib |
| Peficitinib 100 mg | Experimental | Participants will receive a single dose of 100 mg under fasted condition Day 1, followed by multiple doses of 100 mg under fed condition once daily in the morning from Day 8 till Day 13. Receives: Drug: peficitinib |
| Peficitinib 150 mg | Experimental | Participants will receive a single dose of 150 mg under fasted condition Day 1, followed by multiple doses of 150 mg under fed condition once daily in the morning from Day 8 till Day 13. Receives: Drug: peficitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a study drug or who has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug.
An AE is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Measured: Up to Day 20
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to Day 20
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to Day 20
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant 12-ECG values.
Measured: Up to Day 20
Number of participants with physical examination abnormalities and/or AEs
Number of participants with potentially clinically significant physical examination observations.
Measured: Up to Day 20
Pharmacokinetics (PK) of peficitinib: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK serum samples collected.
Measured: On Day 1
PK of peficitinib: AUC from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK serum samples collected.
Measured: On Day 1 and 8
PK of peficitinib: AUC from the time of dosing to 24 hours post dose (AUC24h)
AUC24h will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
PK of peficitinib: Apparent total systemic clearance after extravascular dosing (CL/F)
CL/F will be recorded from the PK serum samples collected.
Measured: On Day 1 and 13
PK of peficitinib: Maximum concertation (Cmax)
Cmax will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
PK of peficitinib: Terminal elimination rate constant (Lambdaz)
Lambdaz will be recorded from the PK serum samples collected.
Measured: On Day 1 and 13
PK of peficitinib: Terminal elimination half-life (t1/2)
t1/2 will be recorded from the PK serum samples collected.
Measured: On Day 1 and 13
PK of peficitinib: Time of the maximum concentration (tmax)
tmax will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
PK of peficitinib: Apparent volume of distribution during the terminal elimination phase after single extravascular dosing (VzF)
VzF will be recorded from the PK serum samples collected.
Measured: On Day 1
PK of peficitinib: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK serum samples collected.
Measured: On Day 9 to 12 and 13
PK of peficitinib: Concentration at 24 hours post dosing (C24h)
C24h will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib: Peak trough ratio (PTR)
PTR will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib: Accumulation ratio calculated using AUC (Rac(AUC24h))
Rac(AUC) will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib: Accumulation ratio calculated using the maximum concentration (Rac (Cmax))
Rac(Cmax)will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib metabolite: AUCinf
AUCinf will be recorded from the PK serum samples collected.
Measured: On Day 1
PK of peficitinib metabolite: AUClast
AUClast will be recorded from the PK serum samples collected.
Measured: On Day 1 and 8
PK of peficitinib metabolite: AUC24h
AUC24h will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
PK of peficitinib metabolite: Cmax
Cmax will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
PK of peficitinib metabolite: Lambdaz
Lambdaz will be recorded from the PK serum samples collected.
Measured: On Day 1 and 13
PK of peficitinib metabolite: t1/2
t1/2 will be recorded from the PK serum samples collected.
Measured: On Day 1 and 13
PK of peficitinib metabolite: tmax
tmax will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
PK of peficitinib metabolite: Ctrough
Ctrough will be recorded from the PK serum samples collected.
Measured: On Day 9 to 12 and 13
PK of peficitinib metabolite: C24h
C24h will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib metabolite: PTR
PTR will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib metabolite: Rac(AUC24h)
Rac(AUC24h) will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib metabolite: Rac(Cmax)
Rac(Cmax) will be recorded from the PK serum samples collected.
Measured: On Day 13
PK of peficitinib metabolite: Metabolite to parent ratio of the area under the concentration-time curve corrected by the molecular weight ratio of parent to metabolite (MPR)
MPR will be recorded from the PK serum samples collected.
Measured: On Day 1, 8 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start5 Dec 2019
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Moniter, Senior Manager, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143477
- Sponsor's protocol ID
- 015K-CL-CNA1
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2019
- Last updated
- 21 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/.
Publications
Gao X, He X, Oshima H, Miyatake D, Otsuka Y, Kato K, Cai C, Wojtkowski T, Song N, Kaneko Y, Shi A. Pharmacokinetics and Safety of Single and Multiple Doses of Peficitinib (ASP015K) in Healthy Chinese Subjects. Drug Des Devel Ther. 2022 May 9;16:1365-1381. doi: 10.2147/DDDT.S359501. eCollection 2022.
PubMed 35586186
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04143477
- Acronym / sponsor ID
- 015K-CL-CNA1
- Conditions
- Healthy Volunteers
- Keywords
- peficitinib, ASP015K, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 29 Oct 2019 (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 ASP015K after single-dose and multiple-dose administration in healthy Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peficitinib 50 mg | Experimental | Drug: peficitinibParticipants will receive a single dose of 50 milligrams (mg) under fasted condition Day 1, followed by multiple doses of 50 mg under fed condition once daily in the morning from Day 8 till Day 13. |
| Peficitinib 100 mg | Experimental | Drug: peficitinibParticipants will receive a single dose of 100 mg under fasted condition Day 1, followed by multiple doses of 100 mg under fed condition once daily in the morning from Day 8 till Day 13. |
| Peficitinib 150 mg | Experimental | Drug: peficitinibParticipants will receive a single dose of 150 mg under fasted condition Day 1, followed by multiple doses of 150 mg under fed condition once daily in the morning from Day 8 till Day 13. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal Body Mass index (BMI) and weight: BMI[= weight kg/(height m)^2] > 19 kg/m^2 and ≤ 24 kg/m^2, the weight is no less than 50 kg for male and 45 kg for female at screening.
- Female subject must either: Be of non-childbearing potential, postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile. Or, if of childbearing potential: agree not to try to become pregnant during the study and for 60 days after the final study drug administration, must have a negative pregnancy at Screening and Day -1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
- Female subject must not donate ova starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
- Male subject and female spouse/partners who are of childbearing potential must be using 1 form of highly effective birth control starting at Screening and throughout the study period, and for 90 days after the final study drug administration.
Key exclusion criteria (38 listed)
- Female subject who has been pregnant within 6 months prior to screening or breast feeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
- Subject has any of the liver chemistry tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] and total bilirubin [TBL]) above the upper limit of normal on Day -1. In such a case, the assessment may be repeated once.
- Subjects who meet any of the following criterion for laboratory tests on Day -1. Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study. In such a case, the assessment may be repeated once.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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 |
|---|---|---|
| peficitinibAlso: ASP015KOral | Drug | Peficitinib 100 mg, Peficitinib 150 mg, Peficitinib 50 mg |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to Day 20
An AE is defined as any untoward medical occurrence in a participant administered a study drug or who has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug. An AE is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to Day 20
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to Day 20
Number of participants with potentially clinically significant vital sign values.
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to Day 20
Number of participants with potentially clinically significant 12-ECG values.
Number of participants with physical examination abnormalities and/or AEs
Time frame: Up to Day 20
Number of participants with potentially clinically significant physical examination observations.
Pharmacokinetics (PK) of peficitinib: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: On Day 1
AUCinf will be recorded from the PK serum samples collected.
PK of peficitinib: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: On Day 1 and 8
AUClast will be recorded from the PK serum samples collected.
PK of peficitinib: AUC from the time of dosing to 24 hours post dose (AUC24h)
Time frame: On Day 1, 8 and 13
AUC24h will be recorded from the PK serum samples collected.
PK of peficitinib: Apparent total systemic clearance after extravascular dosing (CL/F)
Time frame: On Day 1 and 13
CL/F will be recorded from the PK serum samples collected.
PK of peficitinib: Maximum concertation (Cmax)
Time frame: On Day 1, 8 and 13
Cmax will be recorded from the PK serum samples collected.
PK of peficitinib: Terminal elimination rate constant (Lambdaz)
Time frame: On Day 1 and 13
Lambdaz will be recorded from the PK serum samples collected.
PK of peficitinib: Terminal elimination half-life (t1/2)
Time frame: On Day 1 and 13
t1/2 will be recorded from the PK serum samples collected.
PK of peficitinib: Time of the maximum concentration (tmax)
Time frame: On Day 1, 8 and 13
tmax will be recorded from the PK serum samples collected.
PK of peficitinib: Apparent volume of distribution during the terminal elimination phase after single extravascular dosing (VzF)
Time frame: On Day 1
VzF will be recorded from the PK serum samples collected.
PK of peficitinib: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: On Day 9 to 12 and 13
Ctrough will be recorded from the PK serum samples collected.
PK of peficitinib: Concentration at 24 hours post dosing (C24h)
Time frame: On Day 13
C24h will be recorded from the PK serum samples collected.
PK of peficitinib: Peak trough ratio (PTR)
Time frame: On Day 13
PTR will be recorded from the PK serum samples collected.
PK of peficitinib: Accumulation ratio calculated using AUC (Rac(AUC24h))
Time frame: On Day 13
Rac(AUC) will be recorded from the PK serum samples collected.
PK of peficitinib: Accumulation ratio calculated using the maximum concentration (Rac (Cmax))
Time frame: On Day 13
Rac(Cmax)will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: AUCinf
Time frame: On Day 1
AUCinf will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: AUClast
Time frame: On Day 1 and 8
AUClast will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: AUC24h
Time frame: On Day 1, 8 and 13
AUC24h will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: Cmax
Time frame: On Day 1, 8 and 13
Cmax will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: Lambdaz
Time frame: On Day 1 and 13
Lambdaz will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: t1/2
Time frame: On Day 1 and 13
t1/2 will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: tmax
Time frame: On Day 1, 8 and 13
tmax will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: Ctrough
Time frame: On Day 9 to 12 and 13
Ctrough will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: C24h
Time frame: On Day 13
C24h will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: PTR
Time frame: On Day 13
PTR will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: Rac(AUC24h)
Time frame: On Day 13
Rac(AUC24h) will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: Rac(Cmax)
Time frame: On Day 13
Rac(Cmax) will be recorded from the PK serum samples collected.
PK of peficitinib metabolite: Metabolite to parent ratio of the area under the concentration-time curve corrected by the molecular weight ratio of parent to metabolite (MPR)
Time frame: On Day 1, 8 and 13
MPR will be recorded from the PK serum 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 21 Oct 2024.
- Derived from this study: PubMed 35586186Gao X, He X, Oshima H, Miyatake D, Otsuka Y, Kato K, Cai C, Wojtkowski T, Song N, Kaneko Y, Shi A. Pharmacokinetics and Safety of Single and Multiple Doses of Peficitinib (ASP015K) in Healthy Chinese Subjects. Drug Des Devel Ther. 2022 May 9;16:1365-1381. doi: 10.2147/DDDT.S359501. eCollection 2022.
- 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.
Medical Moniter, Senior Manager 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 peficitinib 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 7 inclusion and 38 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 21 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 20). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143477, which also lists 1 linked publication.
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 21 Oct 2024.