Pharmacokinetics of ASKP1240Phase 1NCT01582399
Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240
A Phase 1 study testing ASKP1240 in people with Pharmacokinetics of ASKP1240 and Pharmacodynamics of ASKP1240, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of ASKP1240, Pharmacodynamics of ASKP1240, Healthy Volunteers
- What is being tested?
- ASKP1240
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- The female subject must be a) at least two years post-menopausal (defined as at least 2 years without menses) at Screening and a confirmatory follicle stimulating hormone (FSH) level of >40 U/L at Screening) or b) surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating at Screening and Day -1. c) If child bearing potential, the subject will be required to use adequate contraception consisting of two forms of birth control (one of which must be a barrier method) until the end of the study or for 90 days after final study drug administration, whichever is longer
- The male subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method until the end of study
- Male subject agrees to no sperm donation until the end of the study or for 90 days after the conclusion of study drug administration, whichever is longer
Who cannot join
- The subject has a history or evidence of any clinically significant (as determined by the Investigator) cardiovascular, endocrine, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
- The subject has a history of severe allergic or anaphylactic reactions
- The subject has a history of consuming more than 14 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week on average within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening or the subject tests positive at Screening or Day -1 for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates)
- The subject has/had a symptomatic, viral, bacterial or fungal (non-cutaneous) infection within 1 week prior to clinic check in on Day -1
- The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis or pulmonary embolism
- The subject has used any tobacco-containing products, nicotine or nicotine-containing products in the past 6 months prior to Screening
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- The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean heart rate > 100 beats per minute (bpm), either at Screening or Day -1 (measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes)
- The subject is known to be positive for human immunodeficiency virus (HIV) antibody
- The subject has a positive test for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody at Screening
- The subject has the following at Screening or Day -1:
- White blood cell count (WBC) is < 3.5 (109/L) or > upper limit of normal
- Absolute neutrophil count (ANC) is < 1.5 (109/L) or > upper limit of normal
- Platelet count (PLT) is outside the normal limit
- Serum creatinine, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) are > upper limit of normal
- Creatine phosphokinase (CPK) is > 2x times upper limit of normal
- International normalized ratio (INR) is > upper limit of normal
- Remaining laboratory tests are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests
- The subject has received any vaccine within 60 days prior to Day -1
- The subject has received any systemic immunosuppressant agent (e.g., methotrexate) within 6 months prior to Day -1
- The subject has received any systemic steroid within 2 months prior to Day -1
- The subject has received any antibody or therapeutic biologic product within 6 months prior to Day -1
- The subject has used prescription or non-prescription medications (excluding acetaminophen [up to 2 g/day maximum], stable hormone replacement therapy [HRT], and/or nasal steroids/steroid inhaler), or complementary and alternative medicines (CAM) within 14 days or 5 half lives (whichever is longer) prior to Day -1
- The subject has a positive TB skin test, Quantiferon Gold test or T-SPOT test® at Screening
- The subject has participated in a previous ASKP1240 study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single-Dose, Parallel Group, Randomized, Open-Label Study to Determine the Absolute Bioavailability of ASKP1240 After Intravenous and Subcutaneous Administration in Healthy Subjects
The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240.
In addition, the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as SC injection.
- Being tested
- ASKP1240
- Keywords
- Healthy Volunteers, CD40 receptor occupancy, Co-stimulation blockade, CD40 antigen, Anti-CD40, ASKP1240
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKP1240Drug
intravenous(IV) infusion and subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: ASKP1240 intravenous (IV) infusion | Experimental | Not described Receives: Drug: ASKP1240 |
| Arm B: ASKP1240 subcutaneous (SC) | Experimental | Not described Receives: Drug: ASKP1240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile: AUClast, AUCinf, and F
Area under the serum concentration- time curve from time 0 up to the last quantifiable concentration (AUClast), Area under the serum concentration- time curve from time 0 extrapolated to infinity (AUCinf), and Absolute bioavailability (F)
Measured: Day 15 to Day 90, ± 3 days
Secondary outcomes (3)
Pharmacodynamic profile: CD40 receptor occupancy over time
Cell surface antigen, target of ASKP1240 (CD40), as measured on CD20+ B lymphocytes
Measured: Day 15 to Day 90, ± 3 days
Pharmacodynamic profile: Total lymphocyte count and peripheral lymphocyte subset quantification
Total lymphocyte count = product of the white blood count (WBC) and percent lymphocytes [from differential]
Measured: Day 15 to Day 90, ± 3 days
Pharmacokinetics profile: Cmax, Tmax, t1/2, Vz, and CLtot
Maximum concentration (Cmax),Time to attain Cmax (Tmax), Apparent terminal elimination of half-life (t1/2), Apparent volume of distribution ( Vz), and Total body clearance (CLtot)
Measured: Day 15 to Day 90, ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of ASKP1240Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582399
- Sponsor's protocol ID
- 7163-CL-0106
- Status last verified
- Dec 2012
- First submitted
- 19 Apr 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-Dose, Parallel Group, Randomized, Open-Label Study to Determine the Absolute Bioavailability of ASKP1240 After Intravenous and Subcutaneous Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01582399
- Acronym / sponsor ID
- 7163-CL-0106
- Keywords
- Healthy Volunteers, CD40 receptor occupancy, Co-stimulation blockade, CD40 antigen, Anti-CD40, ASKP1240
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd.
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Apr 2012 (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 assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240.
In addition, the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as SC injection.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: ASKP1240 intravenous (IV) infusion | Experimental | Drug: ASKP1240 |
| Arm B: ASKP1240 subcutaneous (SC) | Experimental | Drug: ASKP1240 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- The female subject must be a) at least two years post-menopausal (defined as at least 2 years without menses) at Screening and a confirmatory follicle stimulating hormone (FSH) level of >40 U/L at Screening) or b) surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating at Screening and Day -1. c) If child bearing potential, the subject will be required to use adequate contraception consisting of two forms of birth control (one of which must be a barrier method) until the end of the study or for 90 days after final study drug administration, whichever is longer
- The male subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method until the end of study
- Male subject agrees to no sperm donation until the end of the study or for 90 days after the conclusion of study drug administration, whichever is longer
Key exclusion criteria (24 listed)
- The subject has a history or evidence of any clinically significant (as determined by the Investigator) cardiovascular, endocrine, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
- The subject has a history of severe allergic or anaphylactic reactions
- The subject has a history of consuming more than 14 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week on average within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening or the subject tests positive at Screening or Day -1 for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates)
- The subject has/had a symptomatic, viral, bacterial or fungal (non-cutaneous) infection within 1 week prior to clinic check in on Day -1
- The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis or pulmonary embolism
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 |
|---|---|---|
| ASKP1240intravenous(IV) infusion and subcutaneous (SC) | Drug | Arm A: ASKP1240 intravenous (IV) infusion, Arm B: ASKP1240 subcutaneous (SC) |
Primary outcome
Pharmacokinetic profile: AUClast, AUCinf, and F
Time frame: Day 15 to Day 90, ± 3 days
Area under the serum concentration- time curve from time 0 up to the last quantifiable concentration (AUClast), Area under the serum concentration- time curve from time 0 extrapolated to infinity (AUCinf), and Absolute bioavailability (F)
3 secondary outcomes
Pharmacodynamic profile: CD40 receptor occupancy over time
Time frame: Day 15 to Day 90, ± 3 days
Pharmacodynamic profile: Total lymphocyte count and peripheral lymphocyte subset quantification
Time frame: Day 15 to Day 90, ± 3 days
Pharmacokinetics profile: Cmax, Tmax, t1/2, Vz, and CLtot
Time frame: Day 15 to Day 90, ± 3 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 10 Dec 2012.
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 Global Development
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 ASKP1240 in people with Pharmacokinetics of ASKP1240 and Pharmacodynamics of ASKP1240, run by Astellas Pharma Global Development, Inc. at 1 site 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 4 inclusion and 24 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 10 Dec 2012. 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 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?
Pharmacokinetic profile: AUClast, AUCinf, and F (time frame: Day 15 to Day 90, ± 3 days). 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 10 Dec 2012.