Healthy VolunteersPhase 1NCT01918995
Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
A Phase 1 study testing Regadenoson in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
This study is to determine the safety, tolerability, and pharmacokinetics of two or three repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy supine subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Regadenoson
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject has a body weight of at least 45 kg and a body mass index of 18 to 32 kg/m2, inclusive.
- QTcF must be 430 msec or less for males and 450 msec or less for females. If the mean QTcF exceeds 430 msec for males or 450 msec for females, 1 additional triplicate measurement may be taken. If this triplicate measurement also gives an abnormal QTcF result, the subject should be excluded.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin (TBil) must not be above the normal range. If the Screening test result for AST, ALT, or TBil is > 1 x ULN, but < 1.5 x ULN the assessment may be repeated once during the screening period and on day -1. If the repeat assessment is above the ULN, the subject is not eligible. If the AST, ALT, or TBil test result at Screening is > 1.5 x ULN, it cannot be repeated, and the subject is not eligible.
- Female subject is of non-childbearing potential or if of childbearing potential must use highly effective birth control from Screening through 28 days after the end of the study. Females must not be breastfeeding or donate ova from Screening through 20 days after the end of the study.
- Male subject must be using highly effective contraception from Screening through 90 days after final study drug administration. Male subject must not donate sperm starting at Screening through 90 days after final study drug administration.
Who cannot join
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of either Short or Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes).
- The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies at Screening or is known to be positive for human immunodeficiency virus.
- The subject has a known or suspected allergy to regadenoson or any of the components of the trial products, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions.
- Subject has a history of smoking, regardless of frequency, tobacco type or method of intake, within 6 months prior to first dose of regadenoson.
- The subject has had treatment with any prescribed or non-prescribed drugs in the 2 weeks prior to Day 1, with the exception of occasional use of acetaminophen up to 2 g/day.
- The subject has participated in any interventional clinical study or has received any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to Screening.
- The subject has participated in a prior study with regadenoson.
- The subject has history of consuming more than 14 units of alcoholic beverages per week 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Dose Escalation, Parallel Group, Placebo-controlled, Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
This study is to determine the safety, tolerability, and pharmacokinetics of two or three repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy supine subjects.
Read the detailed description
All subjects will receive up to 3 doses of study drug on day 1 after fasting from all food and drink (except water) for at least 8 hours. Subjects will remain in the clinic for 2 days.
- Conditions
- Healthy Volunteers
- Being tested
- Regadenoson, Placebo
- Keywords
- CVT3146, Regadenoson
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
Also called Lexiscan, CVT3146
Intravenous (IV)
PlaceboDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Regadenoson low dose | Experimental | Administered over approximately 10 seconds followed by 2 repeat low doses at 10 minute intervals Receives: Drug: Regadenoson |
| Regadenoson medium dose | Experimental | Administered over approximately 10 seconds followed by 2 repeat medium doses at 10 minute intervals Receives: Drug: Regadenoson |
| Regadenoson high dose | Experimental | Administered over approximately 10 seconds followed by 1 repeat high dose at 10 minute intervals Receives: Drug: Regadenoson |
| Placebo | Placebo comparator | Administered over approximately 10 seconds followed by 1 or 2 repeat doses at 10 minute intervals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by vital signs
Measured: Pre-dose and up to 24 hours post dose
Secondary outcomes (1)
Safety assessed by electrocardiogram (ECG), laboratory evaluations, and adverse events
Measured: Up to 72 hours after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
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 VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918995
- Sponsor's protocol ID
- 3606-CL-1005
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Townsend R, Desai A, Rammelsberg D, Kowalski D, Simmons N, Kitt TM. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study. J Nucl Cardiol. 2017 Feb;24(1):57-65. doi: 10.1007/s12350-015-0327-9. Epub 2015 Nov 25.
PubMed 26607361
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Dose Escalation, Parallel Group, Placebo-controlled, Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01918995
- Acronym / sponsor ID
- 3606-CL-1005
- Conditions
- Healthy Volunteers
- Keywords
- CVT3146, Regadenoson
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Aug 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.
This study is to determine the safety, tolerability, and pharmacokinetics of two or three repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy supine subjects.
Detailed description
All subjects will receive up to 3 doses of study drug on day 1 after fasting from all food and drink (except water) for at least 8 hours. Subjects will remain in the clinic for 2 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regadenoson low dose | Experimental | Drug: RegadenosonAdministered over approximately 10 seconds followed by 2 repeat low doses at 10 minute intervals |
| Regadenoson medium dose | Experimental | Drug: RegadenosonAdministered over approximately 10 seconds followed by 2 repeat medium doses at 10 minute intervals |
| Regadenoson high dose | Experimental | Drug: RegadenosonAdministered over approximately 10 seconds followed by 1 repeat high dose at 10 minute intervals |
| Placebo | Placebo comparator | Drug: PlaceboAdministered over approximately 10 seconds followed by 1 or 2 repeat doses at 10 minute intervals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject has a body weight of at least 45 kg and a body mass index of 18 to 32 kg/m2, inclusive.
- QTcF must be 430 msec or less for males and 450 msec or less for females. If the mean QTcF exceeds 430 msec for males or 450 msec for females, 1 additional triplicate measurement may be taken. If this triplicate measurement also gives an abnormal QTcF result, the subject should be excluded.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin (TBil) must not be above the normal range. If the Screening test result for AST, ALT, or TBil is > 1 x ULN, but < 1.5 x ULN the assessment may be repeated once during the screening period and on day -1. If the repeat assessment is above the ULN, the subject is not eligible. If the AST, ALT, or TBil test result at Screening is > 1.5 x ULN, it cannot be repeated, and the subject is not eligible.
- Female subject is of non-childbearing potential or if of childbearing potential must use highly effective birth control from Screening through 28 days after the end of the study. Females must not be breastfeeding or donate ova from Screening through 20 days after the end of the study.
- Male subject must be using highly effective contraception from Screening through 90 days after final study drug administration. Male subject must not donate sperm starting at Screening through 90 days after final study drug administration.
Key exclusion criteria (8 listed)
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of either Short or Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes).
- The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies at Screening or is known to be positive for human immunodeficiency virus.
- The subject has a known or suspected allergy to regadenoson or any of the components of the trial products, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions.
- Subject has a history of smoking, regardless of frequency, tobacco type or method of intake, within 6 months prior to first dose of regadenoson.
- The subject has had treatment with any prescribed or non-prescribed drugs in the 2 weeks prior to Day 1, with the exception of occasional use of acetaminophen up to 2 g/day.
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 |
|---|---|---|
| RegadenosonAlso: Lexiscan, CVT3146Intravenous (IV) | Drug | Regadenoson high dose, Regadenoson low dose, Regadenoson medium dose |
| PlaceboIntravenous (IV) | Drug | Placebo |
Primary outcome
Safety assessed by vital signs
Time frame: Pre-dose and up to 24 hours post dose
1 secondary outcome
Safety assessed by electrocardiogram (ECG), laboratory evaluations, and adverse events
Time frame: Up to 72 hours after last dose of study drug
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 30 Aug 2013.
- Derived from this study: PubMed 26607361Townsend R, Desai A, Rammelsberg D, Kowalski D, Simmons N, Kitt TM. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study. J Nucl Cardiol. 2017 Feb;24(1):57-65. doi: 10.1007/s12350-015-0327-9. Epub 2015 Nov 25.
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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.
Senior Medical Director study director
Astellas Pharma Global Development, 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 Regadenoson in people with Healthy Volunteers, 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 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 30 Aug 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 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. 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?
Safety assessed by vital signs (time frame: Pre-dose and up to 24 hours post dose). 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 NCT01918995, 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 30 Aug 2013.