Healthy VolunteersPhase 1NCT02531191
Bioequivalence Evaluation of a New and Current Tablet of ASP015K
A Phase 1 study testing peficitinib in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy 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
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jun 2015to 15 Jul 2015
- 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 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 50.0 kg ≤ body weight at screening < 80.0 kg
- 17.6 ≤ BMI at screening < 26.4 [BMI = Body weight (kg) / (Body height (m))2]
- Subjects who agree to use the following highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at written informed consent through 90 days after the study drug administration in Period 2.
- Subjects who agree not to donate sperm starting at informed consent through 90 days after the study drug administration in Period 2.
- Subjects judged as healthy by investigator or sub-investigator based on physical examinations (subjective symptoms and objective findings) and all clinical tests obtained at screening and from check-in to immediately before the study drug administration in Period 1.
Who cannot join
- Subjects who have received investigational drugs within 120 days prior to screening or who plan to receive investigational drugs from screening assessment to check-in in Period 1 (Day -1).
- Any blood donation or blood drawing apply the following:
- Whole blood collection (≥ 400 mL): from 90 days prior to screening to check-in in Period 1 (Day -1)
- Whole blood collection (≥ 200 mL): from 30 days prior to screening to check-in in Period 1 (Day -1)
- Platelet or plasma donation: from 30 days prior to screening to check-in in Period 1 (Day -1)
- Subjects who had used or plan to use any prescribed or non-prescribed drugs within 7 days prior to check-in in Period 1 (Day -1).
Show all 50Show fewer
- Any deviation of blood pressure, pulse, body temperature, or 12-lead ECG at screening or check-in in Period 1 (Day -1) from the following normal range:
- Supine pressure: Systolic: ≥ 90 mmHg, ≤ 140 mmHg; Diastolic: ≥ 40 mmHg, ≤ 90 mmHg
- Supine pulse: ≥ 40 bpm, ≤ 99 bpm
- Axillary temperature: ≥ 35.0 ºC, ≤ 37.0 ºC
- 12-lead ECG: Normal or clinically irrelevant abnormality QTc interval: ≥ 330 msec, < 430 msec
- Any deviation of laboratory tests at Screening or on Day -1 (check-in) in Period 1 from the following normal range. Normal range of each test at the test or assay site will be used.
- Hematology: > 20% of upper limit or < 20% of lower limit.
- Chemistry: deviation of ALT, AST, Cre, blood electrolytes (Na, K, Cl), or fasting blood glucose. > 20% of upper limit or < 20% of lower limit in other than above tests; however no lower limit is set with respect to ALT, AST, γ-GTP, T-Bil, ALP, LDH, CK, T-Cho, TG, Cre, and UA.
- Urinalysis (qualitative): deviation in any of the urinalysis.
- Urinary drug abuse test: positive for benzodiazepines, cocaine-based narcotics, analeptic drugs, cannabis, barbituric acid derivatives, morphine-based narcotics, phencyclidines, or tricyclic antidepressants.
- Immunological test: positive for HBs antigen, HBc antibody, HCV antibody, HIV antigen or antibody, or syphilis.
- Subjects who have any history or complication of drug allergies.
- Subjects who have a history of upper gastrointestinal symptoms, i.e. nausea, vomit, stomach ache, etc. within 7 days prior to check-in in Period 1 (Day -1).
- Subjects who have any history or complication of hepatic disease, i.e. viral hepatitis, drug induced liver injury, hepatic dysfunction, etc.
- Subjects who have any history or complication of cardiac disease, i.e. congestive heart failure, angina, arrhythmia requires a treatment, etc.
- Subjects who have any history or complication of respiratory disease, i.e. bronchial asthma, chronic bronchitis, pneumonitis, etc. (except for a history of asthma in childhood)
- Subjects who have any history or complication of gastrointestinal disease, i.e. peptic ulcer, reflux esophagitis, etc. (except for a history of appendicitis)
- Subjects who have any history of gastrointestinal resection (except for a history of appendectomy)
- Subjects who have any history or complication of renal disease, i.e. acute renal failure, glomerulonephritis, intestinal nephritis, etc.
- Subjects who have any history or complication of endocrine disease, i.e. hyperthyroidism, abnormality of growth hormone, etc.
- Subjects who have any history or complication of cerebrovascular disorder, i.e. cerebral infarction.
- Subjects who have any history or complication of malignant tumor.
- Subjects who have any history or complication of congenital short QT syndrome.
- Subjects who have any history or complication of lymphatic disease, i.e. lymphoproliferative disease.
- Subjects any of the following apply regarding tuberculosis:
- History of active tuberculosis
- Abnormality in chest X-ray test at screening
- Contact with patients with infectious tuberculosis
- Subjects any of the following apply regarding infectious disease other than tuberculosis:
- History or complication of serious herpes zoster or disseminated herpes zoster
- More than once relapse of localized herpes zoster
- Hospitalization due to serious infection within 90 days before check-in in Period 1 (Day -1)
- I.V. antibiotics treatment within 90 days before check-in in Period 1 (Day -1) (except for prevention use)
- Judged as prone to infections by investigator or sub-investigator, i.e. subjects with urethral catheterization.
- Subjects who have any history of inoculation of live vaccine or attenuated live vaccine within 56 days prior to check-in in Period 1 (Day -1).
- Subjects who have any history of clinically serious allergy (Clinically serious allergy; allergy induced systemic urticaria or anaphylactic shock require hospitalization when exposed to specific antigens or drugs).
- Subjects who have any history or complication of heart failure classified as NYHA Class III or IV.
- Subjects who have a history of ASP015K administration.
- Subjects with excessive alcohol drinking or smoking.
- Criteria for "excessive":
- Smoking: ≥ 20 cigarettes/day
- Alcohol drinking: ≥ 45 g/day (a large bottle of beer contains 25 g of alcohol, 1 gou of Japanese sake contains 22 g of alcohol)
- Employee of the sponsor, CROs or study site involved in this study.
- Subjects judged as inappropriate for the study by investigator or sub-investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP015K Pharmacokinetic Study - Bioequivalence Evaluation of a Small and Current Tablet of ASP015K
The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
Read the detailed description
This is an open-label, randomized, single dose, 2-way crossover designed study. Forty non-elderly healthy male subjects will receive an ASP015K small tablet or an ASP015K current tablet in each period under fasted conditions. If the bioequivalence between two tablets cannot be demonstrated because of an insufficient number, an add-on subject study will be conducted as needed. The design of the add-on subject study will be the same with that of the initial study.
- Conditions
- Healthy Volunteers
- Being tested
- peficitinib
- Keywords
- ASP015K, bioequivalence study, JAK inhibitor
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 |
|---|---|---|
| New Tablet Preceding Group | Experimental | Each subject received an ASP015K small tablet in period 1 and an ASP015K current tablet in period 2 under fasted conditions with 200 mL of water. Receives: Drug: peficitinib |
| Current Tablet Preceding Group | Experimental | Each subject received an ASP015K current tablet in period 1 and an ASP015K small tablet in period 2 under fasted conditions with 200 mL of water. Receives: Drug: peficitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt)
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) parameter of ASP015K: Maximum concentration (Cmax)
Measured: Up to 72 hours after each study drug dosing
Secondary outcomes (12)
Safety assessed by Adverse Events (AEs)
Measured: Up to 6 days after the study drug dosing of Period 2
Safety assessed by Vital signs
Vital signs include systolic and diastolic blood pressures, pulse rate and temperature.
Measured: Up to 6 days after the study drug dosing of Period 2
Safety assessed by Laboratory tests
Laboratory tests include hematology, biochemistry, urinalysis.
Measured: Up to 6 days after the study drug dosing of Period 2
Safety assessed by 12-lead ECGs
12-lead ECG: 12-lead electrocardiogram
Measured: Up to 6 days after the study drug dosing of Period 2
Pharmacokinetics (PK) profile of ASP015K: AUCinf
AUCinf: AUC from the time of dosing extrapolated to time infinity
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: AUClast
AUClast: AUC from the time of dosing to the last measurable concentration
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: CL/F
CL/F: Apparent total systemic clearance
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: kel
kel: Terminal elimination rate constant
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: MRTinf
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: t1/2
t1/2: Terminal elimination half-life
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: tmax
tmax: Time of Cmax (Maximum concentration)
Measured: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: Vz/F
Apparent volume of distribution during the terminal elimination phase
Measured: Up to 72 hours after each study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start21 Jun 2015
- Primary completion15 Jul 2015
- Study completion15 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531191
- Sponsor's protocol ID
- 015K-CL-PK27
- Status last verified
- Sep 2019
- First submitted
- 30 Jul 2015
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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
Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
PubMed 33068028Shibata M, Toyoshima J, Kaneko Y, Oda K, Kiyota T, Kambayashi A, Nishimura T. The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Mar;10(3):283-290. doi: 10.1002/cpdd.843. Epub 2020 Jul 3.
PubMed 32618438
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP015K Pharmacokinetic Study - Bioequivalence Evaluation of a Small and Current Tablet of ASP015K
- ClinicalTrials.gov ID
- NCT02531191
- Acronym / sponsor ID
- 015K-CL-PK27
- Conditions
- Healthy Volunteers
- Keywords
- ASP015K, bioequivalence study, JAK inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2015 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 24 Aug 2015 (estimated)
- 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 objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
Detailed description
This is an open-label, randomized, single dose, 2-way crossover designed study. Forty non-elderly healthy male subjects will receive an ASP015K small tablet or an ASP015K current tablet in each period under fasted conditions. If the bioequivalence between two tablets cannot be demonstrated because of an insufficient number, an add-on subject study will be conducted as needed. The design of the add-on subject study will be the same with that of the initial study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Tablet Preceding Group | Experimental | Drug: peficitinibEach subject received an ASP015K small tablet in period 1 and an ASP015K current tablet in period 2 under fasted conditions with 200 mL of water. |
| Current Tablet Preceding Group | Experimental | Drug: peficitinibEach subject received an ASP015K current tablet in period 1 and an ASP015K small tablet in period 2 under fasted conditions with 200 mL of water. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 50.0 kg ≤ body weight at screening < 80.0 kg
- 17.6 ≤ BMI at screening < 26.4 [BMI = Body weight (kg) / (Body height (m))2]
- Subjects who agree to use the following highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at written informed consent through 90 days after the study drug administration in Period 2.
- Subjects who agree not to donate sperm starting at informed consent through 90 days after the study drug administration in Period 2.
- Subjects judged as healthy by investigator or sub-investigator based on physical examinations (subjective symptoms and objective findings) and all clinical tests obtained at screening and from check-in to immediately before the study drug administration in Period 1.
Key exclusion criteria (50 listed)
- Subjects who have received investigational drugs within 120 days prior to screening or who plan to receive investigational drugs from screening assessment to check-in in Period 1 (Day -1).
- Any blood donation or blood drawing apply the following:
- Subjects who had used or plan to use any prescribed or non-prescribed drugs within 7 days prior to check-in in Period 1 (Day -1).
- Any deviation of blood pressure, pulse, body temperature, or 12-lead ECG at screening or check-in in Period 1 (Day -1) from the following normal range:
- Any deviation of laboratory tests at Screening or on Day -1 (check-in) in Period 1 from the following normal range. Normal range of each test at the test or assay site will be used.
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 | Current Tablet Preceding Group, New Tablet Preceding Group |
Primary outcome
Pharmacokinetics (PK) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt)
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) parameter of ASP015K: Maximum concentration (Cmax)
Time frame: Up to 72 hours after each study drug dosing
12 secondary outcomes
Safety assessed by Adverse Events (AEs)
Time frame: Up to 6 days after the study drug dosing of Period 2
Safety assessed by Vital signs
Time frame: Up to 6 days after the study drug dosing of Period 2
Safety assessed by Laboratory tests
Time frame: Up to 6 days after the study drug dosing of Period 2
Safety assessed by 12-lead ECGs
Time frame: Up to 6 days after the study drug dosing of Period 2
Pharmacokinetics (PK) profile of ASP015K: AUCinf
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: AUClast
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: CL/F
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: kel
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: MRTinf
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: t1/2
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: tmax
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: Vz/F
Time frame: Up to 72 hours after each study drug dosing
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 16 Oct 2024.
- Derived from this study: PubMed 33068028Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
- Derived from this study: PubMed 32618438Shibata M, Toyoshima J, Kaneko Y, Oda K, Kiyota T, Kambayashi A, Nishimura T. The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Mar;10(3):283-290. doi: 10.1002/cpdd.843. Epub 2020 Jul 3.
- 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 Director study director
Astellas Pharma 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 Inc at 1 site in Japan.
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 5 inclusion and 50 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 16 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 Japan. 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) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt) (time frame: Up to 72 hours after each study drug dosing). The study lists 2 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 NCT02531191, which also lists 2 linked publications.
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 16 Oct 2024.