PharmacokineticsPhase 1NCT01815684
A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects
A Phase 1 study testing ASP3652 in people with Pharmacokinetics and Pharmacodynamics, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.
Trial summary
The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects
- What is being tested?
- ASP3652
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to Dec 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
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0kg/m2.
- Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
- Female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy.
Who cannot join
- Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only).
- Known or suspected hypersensitivity to ASP3652, or any components of the formulation used.
- A mean QTc(F) interval of >430 ms (for males) and >450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). In case of an abnormal QTc(F) interval, the assessment may be repeated once (in triplicate). If the QTc(F) interval exceeds the limits, two additional Electrocardiogram (ECG)s can be recorded and the average of the three QTc(F) values should be used to determine the subject's eligibility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double Blind, Placebo-controlled, Randomized 4-way Alternating Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Ascending Doses of ASP3652 in Healthy Young Caucasian Male and Female Subjects
The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects.
Read the detailed description
Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching placebo during one randomly selected investigational period. Randomization is conducted separately for males and females.
The washout period between dosing occasions is at least 7 days. Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic in the afternoon of Day -1 of investigational period 1, 2, 3 and 4 for pre-dose assessments.
On Day -1 of all investigational periods, subjects do not take any food or drink for at least 10 hours before the anticipated dosing time on Day 1. For the duration of their stay in the clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks.
The subjects are discharged on Day 4 of each investigational period. The End of Study Visit (ESV) is planned to take place 7-14 days after early discharge or after Day 4 of investigational period 4.
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Safety
- Being tested
- ASP3652, Placebo
- Keywords
- Phase I, ASP3652, Dose escalation, Maximum Tolerated Dose (MTD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3652Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP3652 Group 1 | Experimental | Dosed according to the following scheme: placebo, low dose, medium dose, high dose Receives: Drug: ASP3652; Drug: Placebo |
| ASP3652 Group 2 | Experimental | Dosed according to the following scheme: low dose, placebo, medium dose, high dose Receives: Drug: ASP3652; Drug: Placebo |
| ASP3652 Group 3 | Experimental | Dosed according to the following scheme: low dose, medium dose, placebo, high dose Receives: Drug: ASP3652; Drug: Placebo |
| ASP3652 Group 4 | Experimental | Dosed according to the following scheme: low dose, medium dose, high dose, placebo Receives: Drug: ASP3652; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single ascending doses of ASP3652 assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments
Measured: Day -22 to ESV (7-14 days after (early) discharge)
Safety and tolerability of single ascending doses of ASP3652 assessed through electrocardiogram
QT (Q wave to T wave)/QTc interval (QT interval corrected for heart rate), QT interval, RR (R wave to R wave) interval, HR (Heart Rate), PR interval, QRS interval, QTcB, QTcF
Measured: Day -22 to ESV (7-14 days after (early) discharge)
Secondary outcomes (3)
Pharmacokinetic profile of single ascending doses of ASP3652
Plasma: Cmax (Maximum concentration), AUClast (AUC until last sample taken), AUCinf (AUC extrapolated until infinity), tmax (Time to attain Cmax), tlag (Absorption lag time), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance)/ Urine: Aelast (Amount excreted in urine until last sample), Aeinf (Cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose), Aelast% (Percentage of unchanged drug excreted into the urine from time of last measurable concentration), Aeinf% (Percentage of unchanged drug excreted into the urine from time zero to infinity after single dose), CLR (Renal clearance)
Measured: Days 1- 4 (Investigational period 1 - 4)
Effect of single ascending doses of ASP3652 on CNS Pharmacodynamics
Body sway, alertness, perception, mood, learning, memory, distraction, adaptive tracking, eye movements, addiction, neuro-endocrine parameters
Measured: Days 1 - 4 (Investigational period 1 - 4)
Effect of single ascending doses of ASP3652 on plasma levels of enzyme substrates
Rmax, tmax R, AUR
Measured: Days 1 - 4 (Investigational period 1 - 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
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 PharmacokineticsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815684
- Sponsor's protocol ID
- 3652-CL-0049
- Other IDs
- 2011-004247-41
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Takizawa M, Cerneus D, Michon I, Rijnders S, Meijer J, Someya A, Sato Y. Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels. Adv Ther. 2020 Sep;37(9):3967-3984. doi: 10.1007/s12325-020-01451-6. Epub 2020 Jul 26.
PubMed 32715381
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Placebo-controlled, Randomized 4-way Alternating Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Ascending Doses of ASP3652 in Healthy Young Caucasian Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01815684
- Acronym / sponsor ID
- 3652-CL-0049
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Safety
- Keywords
- Phase I, ASP3652, Dose escalation, Maximum Tolerated Dose (MTD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Mar 2013 (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 purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects.
Detailed description
Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching placebo during one randomly selected investigational period. Randomization is conducted separately for males and females.
The washout period between dosing occasions is at least 7 days. Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic in the afternoon of Day -1 of investigational period 1, 2, 3 and 4 for pre-dose assessments.
On Day -1 of all investigational periods, subjects do not take any food or drink for at least 10 hours before the anticipated dosing time on Day 1. For the duration of their stay in the clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks.
The subjects are discharged on Day 4 of each investigational period. The End of Study Visit (ESV) is planned to take place 7-14 days after early discharge or after Day 4 of investigational period 4.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP3652 Group 1 | Experimental | Drug: ASP3652, Drug: PlaceboDosed according to the following scheme: placebo, low dose, medium dose, high dose |
| ASP3652 Group 2 | Experimental | Drug: ASP3652, Drug: PlaceboDosed according to the following scheme: low dose, placebo, medium dose, high dose |
| ASP3652 Group 3 | Experimental | Drug: ASP3652, Drug: PlaceboDosed according to the following scheme: low dose, medium dose, placebo, high dose |
| ASP3652 Group 4 | Experimental | Drug: ASP3652, Drug: PlaceboDosed according to the following scheme: low dose, medium dose, high dose, placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0kg/m2.
- Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
- Female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy.
Key exclusion criteria (3 listed)
- Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only).
- Known or suspected hypersensitivity to ASP3652, or any components of the formulation used.
- A mean QTc(F) interval of >430 ms (for males) and >450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). In case of an abnormal QTc(F) interval, the assessment may be repeated once (in triplicate). If the QTc(F) interval exceeds the limits, two additional Electrocardiogram (ECG)s can be recorded and the average of the three QTc(F) values should be used to determine the subject's eligibility.
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 |
|---|---|---|
| ASP3652Oral | Drug | ASP3652 Group 1, ASP3652 Group 2, ASP3652 Group 3, ASP3652 Group 4 |
| PlaceboOral | Drug | ASP3652 Group 1, ASP3652 Group 2, ASP3652 Group 3, ASP3652 Group 4 |
Primary outcome
Safety and tolerability of single ascending doses of ASP3652 assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments
Time frame: Day -22 to ESV (7-14 days after (early) discharge)
Safety and tolerability of single ascending doses of ASP3652 assessed through electrocardiogram
Time frame: Day -22 to ESV (7-14 days after (early) discharge)
QT (Q wave to T wave)/QTc interval (QT interval corrected for heart rate), QT interval, RR (R wave to R wave) interval, HR (Heart Rate), PR interval, QRS interval, QTcB, QTcF
3 secondary outcomes
Pharmacokinetic profile of single ascending doses of ASP3652
Time frame: Days 1- 4 (Investigational period 1 - 4)
Effect of single ascending doses of ASP3652 on CNS Pharmacodynamics
Time frame: Days 1 - 4 (Investigational period 1 - 4)
Effect of single ascending doses of ASP3652 on plasma levels of enzyme substrates
Time frame: Days 1 - 4 (Investigational period 1 - 4)
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 Mar 2013.
- Derived from this study: PubMed 32715381Takizawa M, Cerneus D, Michon I, Rijnders S, Meijer J, Someya A, Sato Y. Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels. Adv Ther. 2020 Sep;37(9):3967-3984. doi: 10.1007/s12325-020-01451-6. Epub 2020 Jul 26.
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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.
Study Manager study chair
Astellas Pharma Europe B.V.
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 ASP3652 in people with Pharmacokinetics and Pharmacodynamics, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.
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 3 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 Mar 2013. 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 Netherlands. 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?
Safety and tolerability of single ascending doses of ASP3652 assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments (time frame: Day -22 to ESV (7-14 days after (early) discharge)). 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 NCT01815684, 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 Mar 2013.