Pharmacokinetics of ASP015KPhase 1NCT01225224
Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers
A Phase 1 study testing peficitinib in people with Pharmacokinetics of ASP015K and Healthy Volunteer, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men. 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
- Pharmacokinetics of ASP015K, Healthy Volunteer
- What is being tested?
- peficitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- 18 Nov 2009to 10 Mar 2010
- 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
- Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results
- Weight
- Japanese: ≥ 50.0 kg to < 80.0 kg
- Caucasians: ≥ 50.0 kg to < 100.0 kg
- BMI
- Japanese: ≥ 17.6 kg/m2 to < 26.4 kg/m2
- Caucasians: ≥ 18.0 kg/m2 to < 30.0 kg/m2
- Written informed consent obtained from the subject personally
Who cannot join
- Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study
- Collection of 400 mL of whole blood within 90 days prior to the study,
- 200 mL of whole blood within 30 days prior to the study or blood components within 14 days prior to the study
- Received or is scheduled to receive drug treatment within 7 days prior to the drug administration
- A history of drug allergies
- Upper gastrointestinal symptoms, e.g., nausea, vomiting or stomachache, within 7 days prior to the drug admission
Show all 15Show fewer
- Concurrent or previous liver disease, e.g., viral hepatitis or drug-induced hepatic injury
- Concurrent or previous heart disease, e.g., congestive heart failure, angina pectoris or arrhythmias requiring treatment
- Concurrent or previous kidney disease, e.g., acute renal failure,
- glomerulonephritis or interstitial nephritis (except for previous urinary
- calculus)
- Concurrent or previous cerebrovascular disease, e.g., cerebral infarction
- Concurrent or previous malignancy
- Concurrent or previous active or recurrent infection, e.g., hepatitis B,
- hepatitis C or syphilis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
Read the detailed description
This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.
- Conditions
- Pharmacokinetics of ASP015K, Healthy Volunteer
- Being tested
- peficitinib, Placebo
- Keywords
- ASP015K, Ethnic difference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peficitinibDrug
Also called ASP015K
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP015K Single Japanese Group | Experimental | Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. Receives: Drug: peficitinib |
| ASP015K Single Caucasian Group | Experimental | Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. Receives: Drug: peficitinib |
| Placebo Single Japanese Group | Placebo comparator | Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. Receives: Drug: Placebo |
| Placebo Single Caucasian Group | Placebo comparator | Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. Receives: Drug: Placebo |
| ASP015K Multiple Group | Experimental | Participants will receive ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K will be administered at 12-hour intervals after breakfast and dinner for seven days. Receives: Drug: peficitinib |
| Placebo Multiple Group | Placebo comparator | Participants will receive placebo in three stages, each stage corresponding to a different dosage level. Placebo will be administered at 12-hour intervals after breakfast and dinner for seven days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests
Measured: For 48 hours after administration
Secondary outcomes (3)
Plasma unchanged drug concentration
Measured: For 48 hours after administration
Urinary unchanged drug concentration
Measured: For 48 hours after administration
Transcription factor phosphorylation level
Measured: For 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study start18 Nov 2009
- Primary completion10 Mar 2010
- Study completion10 Mar 2010
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 Pharmacokinetics of ASP015KStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225224
- Sponsor's protocol ID
- 015K-CL-HV03
- Status last verified
- Sep 2019
- First submitted
- 19 Oct 2010
- 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
Shibata M, Hatta T, Saito M, Toyoshima J, Kaneko Y, Oda K, Nishimura T. Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects. Clin Drug Investig. 2020 May;40(5):469-484. doi: 10.1007/s40261-020-00910-w.
PubMed 32274653
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
- Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
- ClinicalTrials.gov ID
- NCT01225224
- Acronym / sponsor ID
- 015K-CL-HV03
- Conditions
- Pharmacokinetics of ASP015K, Healthy Volunteer
- Keywords
- ASP015K, Ethnic difference
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2009 (actual)
- Primary completion
- 10 Mar 2010 (actual)
- Study completion
- 10 Mar 2010 (actual)
- First posted
- 20 Oct 2010 (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.
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
Detailed description
This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ASP015K Single Japanese Group | Experimental | Drug: peficitinibParticipants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. |
| ASP015K Single Caucasian Group | Experimental | Drug: peficitinibParticipants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. |
| Placebo Single Japanese Group | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. |
| Placebo Single Caucasian Group | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. |
| ASP015K Multiple Group | Experimental | Drug: peficitinibParticipants will receive ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K will be administered at 12-hour intervals after breakfast and dinner for seven days. |
| Placebo Multiple Group | Placebo comparator | Drug: PlaceboParticipants will receive placebo in three stages, each stage corresponding to a different dosage level. Placebo will be administered at 12-hour intervals after breakfast and dinner for seven days. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results
- Weight
- BMI
- Written informed consent obtained from the subject personally
Key exclusion criteria (15 listed)
- Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study
- Collection of 400 mL of whole blood within 90 days prior to the study,
- 200 mL of whole blood within 30 days prior to the study or blood components within 14 days prior to the study
- Received or is scheduled to receive drug treatment within 7 days prior to the drug administration
- A history of drug allergies
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 | ASP015K Multiple Group, ASP015K Single Caucasian Group, ASP015K Single Japanese Group |
| Placebooral | Drug | Placebo Multiple Group, Placebo Single Caucasian Group, Placebo Single Japanese Group |
Primary outcome
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests
Time frame: For 48 hours after administration
3 secondary outcomes
Plasma unchanged drug concentration
Time frame: For 48 hours after administration
Urinary unchanged drug concentration
Time frame: For 48 hours after administration
Transcription factor phosphorylation level
Time frame: For 48 hours after administration
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 32274653Shibata M, Hatta T, Saito M, Toyoshima J, Kaneko Y, Oda K, Nishimura T. Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects. Clin Drug Investig. 2020 May;40(5):469-484. doi: 10.1007/s40261-020-00910-w.
- 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/.
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.
Use Central Contact study chair
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 Pharmacokinetics of ASP015K and Healthy Volunteer, 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 8 inclusion and 15 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. Some participants in this study may receive a placebo. 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?
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests (time frame: For 48 hours after administration). 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 NCT01225224, 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 16 Oct 2024.