HealthyPhase 1NCT01115946
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers
A Phase 1 study testing ASP1585 and enalapril in people with Healthy and Pharmacokinetics of Enalapril, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method. 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
- Healthy, Pharmacokinetics of Enalapril
- What is being tested?
- ASP1585 and enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2010to Apr 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
- Body weight: =<50.0kg, <80.0kg
- Body mass index: =<17.6, <26.4
- Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data
Who cannot join
- Attending another clinical trial within 120 days before the study
- Blood donation within 90 days (400ml) or 30 days (200ml) before the study
- Receiving any drugs within 7 days before the study
- History of allergy to drugs
- Having GI disorders
- History or complication of liver diseases
Show all 10Show fewer
- History or complication of heart disease
- History or complication of respiratory diseases
- History or complication of renal diseases
- History or complication of cerebrovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Enalapril -
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.
- Conditions
- Healthy, Pharmacokinetics of Enalapril
- Being tested
- ASP1585, enalapril
- Keywords
- ASP1585, Drug-drug interaction, enalapril, Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1585Drug
oral
enalaprilDrug
Also called Renivace
oral
| Study group | Role | What they receive |
|---|---|---|
| single-add first group | Experimental | single administration first, then concomitant administration Receives: Drug: ASP1585; Drug: enalapril |
| combi-add first group | Experimental | concomitant administration first, then single administration Receives: Drug: ASP1585; Drug: enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of enalapril
Measured: for 48 hours after administration
Secondary outcomes (1)
Safety assessed by AE, vital signs 12-lead ECG and lab tests
Measured: for 7 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionApr 2010
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115946
- Sponsor's protocol ID
- 1585-CL-0008
- Status last verified
- May 2010
- First submitted
- 3 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Enalapril -
- ClinicalTrials.gov ID
- NCT01115946
- Acronym / sponsor ID
- 1585-CL-0008
- Conditions
- Healthy, Pharmacokinetics of Enalapril
- Keywords
- ASP1585, Drug-drug interaction, enalapril, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 May 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.
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-add first group | Experimental | Drug: ASP1585, Drug: enalaprilsingle administration first, then concomitant administration |
| combi-add first group | Experimental | Drug: ASP1585, Drug: enalaprilconcomitant administration first, then single administration |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight: =<50.0kg, <80.0kg
- Body mass index: =<17.6, <26.4
- Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data
Key exclusion criteria (10 listed)
- Attending another clinical trial within 120 days before the study
- Blood donation within 90 days (400ml) or 30 days (200ml) before the study
- Receiving any drugs within 7 days before the study
- History of allergy to drugs
- Having GI disorders
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 |
|---|---|---|
| ASP1585oral | Drug | combi-add first group, single-add first group |
| enalaprilAlso: Renivaceoral | Drug | combi-add first group, single-add first group |
Primary outcome
Plasma concentration of enalapril
Time frame: for 48 hours after administration
1 secondary outcome
Safety assessed by AE, vital signs 12-lead ECG and lab tests
Time frame: for 7 days 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 27 May 2010.
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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 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 ASP1585 and enalapril in people with Healthy and Pharmacokinetics of Enalapril, 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 3 inclusion and 10 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 27 May 2010. 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. 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?
Plasma concentration of enalapril (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?
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 27 May 2010.