Healthy SubjectsPhase 1NCT02796118
Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects
A Phase 1 study testing ASP2151 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ASP2151
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2006to Oct 2006
- 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 79 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight: ≥50.0 kg and <85.0 kg
- Body mass index (BMI): ≥17.6 and <26.4 kg/m2
Who cannot join
- Subjects with a complication of any diseases
- Subjects with a history of hepatic disease
- Subjects with a history of heart disease
- Subjects with a history of respiratory disease
- Subjects with a history of alimentary disease
- Subjects with a history of renal disease
Show all 18Show fewer
- Subjects with a history of cerebrovascular disorder
- Subjects with a history of malignant tumor
- Subjects with a history of drug allergies or allergies disorders excluding pollinosis
- Subjects with a history of drug dependency or alcohol dependence syndrome
- Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
- Subjects who do not meet any of the criteria for laboratory tests
- Subjects who received medications within 14 days before the initial dosing.
- Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
- Excessive alcohol drinking or smoking habit
- Subjects who previously received administration of ASP2151 (including placebo)
- Abnormalities detected on an ophthalmological examination
- Subjects who deviate from the normal range of standard 12-lead ECG at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-
The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.
- Conditions
- Healthy Subjects
- Being tested
- ASP2151, Placebo
- Keywords
- Pharmacokinetics, Healthy non-elderly and elderly subjects, ASP2151, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2151Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP2151 Low dose in non-elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. Receives: Drug: ASP2151 |
| ASP2151 High dose in non-elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. Receives: Drug: ASP2151 |
| ASP2151 Low dose in elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. Receives: Drug: ASP2151 |
| ASP2151 High dose in elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. Receives: Drug: ASP2151 |
| Placebo in non-elderly subjects group | Placebo comparator | Subjects will receive matching placebo daily on Days 1 to 7. Receives: Drug: Placebo |
| Placebo in elderly subjects group | Placebo comparator | Subjects will receive matching placebo daily on Days 1 to 7. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of ASP2151 in plasma: Cmax
Cmax: Maximum concentration
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: tmax
tmax: The time after dosing when Cmax occurs
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: t1/2
t1/2: Apparent terminal elimination half-life
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: C24
C24: Concentration at 24hours after dosing
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: AUC24
AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: CL/F
CL/F: Apparent total systemic clearance
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Ae
Ae: Amount excreted in urine
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Cumulative Ae
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Ae%
Ae%: Percent of ASP2151 amount excreted in urine
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Cumulative Ae%
Measured: Up to Day 9
Pharmacokinetics of ASP2151 in urine: CLR
CLR: Renal clearance
Measured: Up to Day 9
Safety assessed by laboratory test: Hematology
Measured: Up to Day 14
Safety assessed by laboratory test: blood biochemistry
Measured: Up to Day 14
Safety assessed by laboratory test: urinalysis
Measured: Up to Day 14
Safety assessed by Vital sign measurement: axillary body temperature
Measured: Up to Day 14
Safety assessed by vital sign measurement: supine blood pressure
Measured: Up to Day 14
Safety assessed by vital sign measurement: supine pulse rate
Measured: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram
Measured: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram for QT assessment
Measured: Up to Day 14
Safety assessed by ophthalmological examination
Measured: Up to Day 14
Safety assessed by incidence of adverse events
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2006
- Primary completionOct 2006
- Study completionOct 2006
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 SubjectsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT02796118
- Sponsor's protocol ID
- 15L-CL-003
- Status last verified
- Aug 2016
- First submitted
- 7 Jun 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.
PubMed 29134426
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-
- ClinicalTrials.gov ID
- NCT02796118
- Acronym / sponsor ID
- 15L-CL-003
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Healthy non-elderly and elderly subjects, ASP2151, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 10 Jun 2016 (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 safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ASP2151 Low dose in non-elderly subjects group | Experimental | Drug: ASP2151Subjects will receive ASP2151 daily on Days 1 to 7. |
| ASP2151 High dose in non-elderly subjects group | Experimental | Drug: ASP2151Subjects will receive ASP2151 daily on Days 1 to 7. |
| ASP2151 Low dose in elderly subjects group | Experimental | Drug: ASP2151Subjects will receive ASP2151 daily on Days 1 to 7. |
| ASP2151 High dose in elderly subjects group | Experimental | Drug: ASP2151Subjects will receive ASP2151 daily on Days 1 to 7. |
| Placebo in non-elderly subjects group | Placebo comparator | Drug: PlaceboSubjects will receive matching placebo daily on Days 1 to 7. |
| Placebo in elderly subjects group | Placebo comparator | Drug: PlaceboSubjects will receive matching placebo daily on Days 1 to 7. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body weight: ≥50.0 kg and <85.0 kg
- Body mass index (BMI): ≥17.6 and <26.4 kg/m2
Key exclusion criteria (18 listed)
- Subjects with a complication of any diseases
- Subjects with a history of hepatic disease
- Subjects with a history of heart disease
- Subjects with a history of respiratory disease
- Subjects with a history of alimentary disease
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 |
|---|---|---|
| ASP2151Oral | Drug | ASP2151 High dose in elderly subjects group, ASP2151 High dose in non-elderly subjects group, ASP2151 Low dose in elderly subjects group, ASP2151 Low dose in non-elderly subjects group |
| PlaceboOral | Drug | Placebo in elderly subjects group, Placebo in non-elderly subjects group |
Primary outcome
Pharmacokinetics of ASP2151 in plasma: Cmax
Time frame: Up to Day 9
Cmax: Maximum concentration
Pharmacokinetics of ASP2151 in plasma: tmax
Time frame: Up to Day 9
tmax: The time after dosing when Cmax occurs
Pharmacokinetics of ASP2151 in plasma: t1/2
Time frame: Up to Day 9
t1/2: Apparent terminal elimination half-life
Pharmacokinetics of ASP2151 in plasma: C24
Time frame: Up to Day 9
C24: Concentration at 24hours after dosing
Pharmacokinetics of ASP2151 in plasma: AUC24
Time frame: Up to Day 9
AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Pharmacokinetics of ASP2151 in plasma: AUCinf
Time frame: Up to Day 9
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Pharmacokinetics of ASP2151 in plasma: CL/F
Time frame: Up to Day 9
CL/F: Apparent total systemic clearance
Pharmacokinetics of ASP2151 in urine: Ae
Time frame: Up to Day 9
Ae: Amount excreted in urine
Pharmacokinetics of ASP2151 in urine: Cumulative Ae
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Ae%
Time frame: Up to Day 9
Ae%: Percent of ASP2151 amount excreted in urine
Pharmacokinetics of ASP2151 in urine: Cumulative Ae%
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in urine: CLR
Time frame: Up to Day 9
CLR: Renal clearance
Safety assessed by laboratory test: Hematology
Time frame: Up to Day 14
Safety assessed by laboratory test: blood biochemistry
Time frame: Up to Day 14
Safety assessed by laboratory test: urinalysis
Time frame: Up to Day 14
Safety assessed by Vital sign measurement: axillary body temperature
Time frame: Up to Day 14
Safety assessed by vital sign measurement: supine blood pressure
Time frame: Up to Day 14
Safety assessed by vital sign measurement: supine pulse rate
Time frame: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram
Time frame: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram for QT assessment
Time frame: Up to Day 14
Safety assessed by ophthalmological examination
Time frame: Up to Day 14
Safety assessed by incidence of adverse events
Time frame: Up to Day 14
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 29 Aug 2016.
- Derived from this study: PubMed 29134426Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.
- Individual participant dataSharing planned: Undecided
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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 ASP2151 in people with Healthy Subjects, 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 2 inclusion and 18 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 29 Aug 2016. 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?
Pharmacokinetics of ASP2151 in plasma: Cmax (time frame: Up to Day 9). The study lists 22 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 NCT02796118, 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 29 Aug 2016.