HealthyPhase 1NCT01427387
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
A Phase 1 study testing ASP0456 in people with Healthy and Pharmacokinetics of ASP0456, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared. Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics of ASP0456
- What is being tested?
- ASP0456
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to Sep 2011
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
- Body weight (at screening);
- female ≥40.0 kg,<70.0 kg
- male ≥50.0 kg,<80.0 kg
- BMI(at screening): ≥17.6,<26.4
Who cannot join
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
- Received medication within 10 days before dose is administered or is scheduled to receive medication
- History of drug allergies
- Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
- Concurrent or previous hepatic disease
- Concurrent or previous heart disease
- Concurrent or previous renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.
- Conditions
- Healthy, Pharmacokinetics of ASP0456
- Being tested
- ASP0456, Placebo
- Keywords
- ASP0456, Pharmacokinetics, safety, tolerability, food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP0456Drug
Also called linaclotide
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Part-1 ASP group | Experimental | ASP0456 receiving group Receives: Drug: ASP0456 |
| Part-1 Placebo group | Placebo comparator | Placebo treatment Receives: Drug: Placebo |
| Part-2 group | Experimental | cross-over study group to evaluate food effect on ASP0456 plasma concentration Receives: Drug: ASP0456 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change
Measured: For 48 hours after dosing
Secondary outcomes (1)
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
Measured: For 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Cental Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427387
- Sponsor's protocol ID
- 0456-CL-0012
- Status last verified
- Sep 2011
- First submitted
- 31 Aug 2011
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-
- ClinicalTrials.gov ID
- NCT01427387
- Acronym / sponsor ID
- 0456-CL-0012
- Conditions
- Healthy, Pharmacokinetics of ASP0456
- Keywords
- ASP0456, Pharmacokinetics, safety, tolerability, food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Sep 2011 (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, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part-1 ASP group | Experimental | Drug: ASP0456ASP0456 receiving group |
| Part-1 Placebo group | Placebo comparator | Drug: PlaceboPlacebo treatment |
| Part-2 group | Experimental | Drug: ASP0456cross-over study group to evaluate food effect on ASP0456 plasma concentration |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
- Body weight (at screening);
- BMI(at screening): ≥17.6,<26.4
Key exclusion criteria (8 listed)
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
- Received medication within 10 days before dose is administered or is scheduled to receive medication
- History of drug allergies
- Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
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 |
|---|---|---|
| ASP0456Also: linaclotideoral | Drug | Part-1 ASP group, Part-2 group |
| Placebooral | Drug | Part-1 Placebo group |
Primary outcome
Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change
Time frame: For 48 hours after dosing
1 secondary outcome
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
Time frame: For 48 hours after 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 23 Sep 2011.
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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.
Use Cental 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 ASP0456 in people with Healthy and Pharmacokinetics of ASP0456, 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 8 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 23 Sep 2011. 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 (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change (time frame: For 48 hours after dosing). 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 23 Sep 2011.