HealthyPhase 1NCT00941018
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers
A Phase 1 study testing RX-10001 in people with Healthy, run by Resolvyx Pharmaceuticals, Inc at 1 site in Netherlands.
Trial summary
This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RX-10001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI: 18 - 32 kg/m2, inclusive
- Female subjects: must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal (amenorrhea duration of 12 months)
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks") and grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
- Medical history without major pathology
- Resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI
- Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
- All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
- Willingness to sign the written Informed Consent Form (ICF)
Who cannot join
- Evidence of clinically relevant pathology
- Mental handicap
- History of relevant drug and/or food allergies
- Regular/routine treatment with non-topical medications within 30 days prior to drug administration
- Use of tobacco products (less than 60 days prior to drug administration)
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
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- Use of concomitant medication (including over the counter medication, health supplements, multivitamins and vitamin C, vitamin and omega-3 supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen (paracetamol) is permitted on discretion of the MI.
- Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study.
- Donation of more than 100 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study.
- Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
- Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- Positive screen on HBsAg
- Positive screen on anti HCV
- Positive screen on anti HIV 1/2
- Illness within 5 days prior to (the first) drug administration
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a medical trial in the previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Ascending Single and Multiple Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Food Effect Study of RX-10001 in Healthy Volunteers
This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.
- Conditions
- Healthy
- Being tested
- RX-10001
- Keywords
- Resolvins, RvE1, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-10001Drug
RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
| Study group | Role | What they receive |
|---|---|---|
| SAD cohort 1 | Experimental | Single ascending dose (SAD) cohort 1 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The starting dose will be 300 mg. Subsequent doses will be determined by the pk and safety data from previous cohorts. Receives: Drug: RX-10001 |
| SAD cohort 2 | Experimental | SAD cohort 2 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The doses to be administered will be determined by the pk and safety data from previous cohorts. Receives: Drug: RX-10001 |
| MAD cohort 1 | Experimental | Multiple ascending dose (MAD) cohort 1 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous SAD cohorts. Receives: Drug: RX-10001 |
| MAD cohort 2 | Experimental | MAD cohort 2 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort. Receives: Drug: RX-10001 |
| MAD cohort 3 | Experimental | MAD cohort 3 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohorts. Receives: Drug: RX-10001 |
| MAD cohort 4 | Experimental | MAD cohort 4 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort. Receives: Drug: RX-10001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability following single and multiple ascending oral doses as assessed by adverse events, vital signs, 12-lead ECG, clinical laboratory and physical exam.
Measured: 1 and 7 days
Secondary outcomes (1)
To determine the pk and pharmacodynamics after single and multiple ascending doses
Measured: 1 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resolvyx Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Renger Tiessen, MD PhD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941018
- Sponsor's protocol ID
- RX-10001-002
- Status last verified
- Dec 2009
- First submitted
- 14 Jul 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Ascending Single and Multiple Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Food Effect Study of RX-10001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00941018
- Acronym / sponsor ID
- RX-10001-002
- Conditions
- Healthy
- Keywords
- Resolvins, RvE1, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Resolvyx Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Jul 2009 (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 being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAD cohort 1 | Experimental | Drug: RX-10001Single ascending dose (SAD) cohort 1 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The starting dose will be 300 mg. Subsequent doses will be determined by the pk and safety data from previous cohorts. |
| SAD cohort 2 | Experimental | Drug: RX-10001SAD cohort 2 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The doses to be administered will be determined by the pk and safety data from previous cohorts. |
| MAD cohort 1 | Experimental | Drug: RX-10001Multiple ascending dose (MAD) cohort 1 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous SAD cohorts. |
| MAD cohort 2 | Experimental | Drug: RX-10001MAD cohort 2 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort. |
| MAD cohort 3 | Experimental | Drug: RX-10001MAD cohort 3 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohorts. |
| MAD cohort 4 | Experimental | Drug: RX-10001MAD cohort 4 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BMI: 18 - 32 kg/m2, inclusive
- Female subjects: must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal (amenorrhea duration of 12 months)
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks") and grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
- Medical history without major pathology
- Resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI
Key exclusion criteria (16 listed)
- Evidence of clinically relevant pathology
- Mental handicap
- History of relevant drug and/or food allergies
- Regular/routine treatment with non-topical medications within 30 days prior to drug administration
- Use of tobacco products (less than 60 days prior to drug administration)
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 |
|---|---|---|
| RX-10001RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts. | Drug | MAD cohort 1, MAD cohort 2, MAD cohort 3, MAD cohort 4, SAD cohort 1, SAD cohort 2 |
Primary outcome
Safety and tolerability following single and multiple ascending oral doses as assessed by adverse events, vital signs, 12-lead ECG, clinical laboratory and physical exam.
Time frame: 1 and 7 days
1 secondary outcome
To determine the pk and pharmacodynamics after single and multiple ascending doses
Time frame: 1 and 7 days
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 Dec 2009.
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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.
Renger Tiessen, MD PhD principal investigator
PRA Health Sciences
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 RX-10001 in people with Healthy, run by Resolvyx Pharmaceuticals, Inc at 1 site in Netherlands.
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 8 inclusion and 16 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 Dec 2009. 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 Netherlands. 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?
Safety and tolerability following single and multiple ascending oral doses as assessed by adverse events, vital signs, 12-lead ECG, clinical laboratory and physical exam. (time frame: 1 and 7 days). 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 Dec 2009.