HealthyPhase 1NCT00210054
A Pharmacokinetic Evaluation Study in Healthy Volunteers
A Phase 1 study testing denufosol tetrasodium (INS37217) in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy
- What is being tested?
- denufosol tetrasodium (INS37217)
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Dec 2002
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- are nonsmokers or those subjects whom have not smoked within 6 months
- are within 20% of their ideal body weight
- are healthy on the basis of a pre-trial physical examination
Who cannot join
- history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
- history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
- use of concomitant medication other than hormonal contraceptives and multi-vitamins
- donation of blood in the 60 days preceding the screening visit
- have been diagnosed with HIV, hepatitis B or hepatitis C
About this study
Official title: Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers
The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.
- Conditions
- Healthy
- Being tested
- denufosol tetrasodium (INS37217)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denufosol tetrasodium (INS37217)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
detection and characterization of plasma concentrations of INS37217
Secondary outcomes (1)
Pilot study - not specified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionDec 2002
- Study completionDec 2002
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.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Deterding, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210054
- Sponsor's protocol ID
- 08-105
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2005
- Last updated
- 12 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00210054
- Acronym / sponsor ID
- 08-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 21 Sep 2005 (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 trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- are nonsmokers or those subjects whom have not smoked within 6 months
- are within 20% of their ideal body weight
- are healthy on the basis of a pre-trial physical examination
Key exclusion criteria (5 listed)
- history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
- history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
- use of concomitant medication other than hormonal contraceptives and multi-vitamins
- donation of blood in the 60 days preceding the screening visit
- have been diagnosed with HIV, hepatitis B or hepatitis C
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 |
|---|---|---|
| denufosol tetrasodium (INS37217) | Drug | – |
Primary outcome
detection and characterization of plasma concentrations of INS37217
1 secondary outcome
Pilot study - not specified
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 12 Oct 2015.
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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.
Robin Deterding, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing denufosol tetrasodium (INS37217) in people with Healthy, run by Merck Sharp & Dohme LLC.
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 5 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
detection and characterization of plasma concentrations of INS37217. 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 12 Oct 2015.