HealthyPhase 1NCT00780182
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
A Phase 1 study testing CMX001 in people with Healthy, run by Jazz Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CMX001
- 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 siteUnited States
- Study dates
- Oct 2008to Jan 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and non-childbearing females 18-55 years old
Who cannot join
- Use of an investigational drug and/or treatment within 30 days prior to enrollment.
- Positive HIV, Hepatitis B or Hepatitis C test result
- Tobacco user
- History of GI disease or disorder
- History of positive fecal occult blood test (FOBT)
- Body Mass Index (BMI) > 30 or < 18, or body weight < 50 kg
- Prior abdominal or pelvic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, 3-Way Crossover, Single-Dose Study in Healthy Volunteers Comparing the Bioavailability of CMX001 (HDP-Cidofovir Conjugate) Delivered as a Tablet Formulation vs a Solution Formulation and the Effect of Food on CMX001 Bioavailability
The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.
- Conditions
- Healthy
- Being tested
- CMX001
- Keywords
- Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX001Drug
CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects will receive three 40mg doses of CMX001 as 1)solution fasted, 2)tablet fasted and 3)tablet following a high-fat breakfast. The order in which each subject receives each of the doses will be determined by a randomization code. Receives: Drug: CMX001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC and Cmax of CMX001 and cidofovir
Measured: Each of 3 doses
Secondary outcomes (1)
Clinical and laboratory endpoints and adverse events
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionJan 2009
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 Jazz PharmaceuticalsThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Evin H Sides, III, MD, Principal investigator, AAIPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780182
- Sponsor's protocol ID
- CMX001-103
- Other IDs
- DMID-08-0020
- Status last verified
- Feb 2010
- First submitted
- 23 Oct 2008
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 3-Way Crossover, Single-Dose Study in Healthy Volunteers Comparing the Bioavailability of CMX001 (HDP-Cidofovir Conjugate) Delivered as a Tablet Formulation vs a Solution Formulation and the Effect of Food on CMX001 Bioavailability
- ClinicalTrials.gov ID
- NCT00780182
- Acronym / sponsor ID
- CMX001-103
- Conditions
- Healthy
- Keywords
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Oct 2008 (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 study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CMX001All subjects will receive three 40mg doses of CMX001 as 1)solution fasted, 2)tablet fasted and 3)tablet following a high-fat breakfast. The order in which each subject receives each of the doses will be determined by a randomization code. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males and non-childbearing females 18-55 years old
Key exclusion criteria (7 listed)
- Use of an investigational drug and/or treatment within 30 days prior to enrollment.
- Positive HIV, Hepatitis B or Hepatitis C test result
- Tobacco user
- History of GI disease or disorder
- History of positive fecal occult blood test (FOBT)
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 |
|---|---|---|
| CMX001CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted | Drug | 1 |
Primary outcome
AUC and Cmax of CMX001 and cidofovir
Time frame: Each of 3 doses
1 secondary outcome
Clinical and laboratory endpoints and adverse events
Time frame: Throughout the study
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 2 Feb 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.
Evin H Sides, III, MD principal investigator
AAIPharma
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 CMX001 in people with Healthy, run by Jazz Pharmaceuticals 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 1 inclusion and 7 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 2 Feb 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 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. 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?
AUC and Cmax of CMX001 and cidofovir (time frame: Each of 3 doses). 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 2 Feb 2010.