Drug Reaction to Analgesic NosPhase 1NCT02667106
Phase I Pharmacokinetic Study of RX0041-2
A Phase 1 study testing RX0041-2 in people with Drug Reaction to Analgesic Nos, run by Pharmaceutical Project Solutions, Inc..
Trial summary
This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute, topical, intranasal administration to healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Reaction to Analgesic Nos
- What is being tested?
- RX0041-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥18 but ≤ 80 years of age at the time of dosing.
- BMI ≥ 18 and ≤ 32 at the screening visit.
- Females (if of child-bearing potential and sexually active) and males (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 8 days following administration of study drug. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm, intrauterine device (IUD), condom, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method or withdrawal.
- Willing and able to provide written informed consent and able to understand and comply with protocol requirements.
- During the period of study confinement, subjects will be required to abstain from beverages containing grapefruit juice or caffeine.
Who cannot join
- Has a known allergy to any ester based anesthetics including cocaine HCl, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine Amide based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, mepivicaine, bupivicaine, levobupivicaine, ropivicaine, etidocaine, prilocaine, and articaine.
- The use of amphetamines, methylphenidate or other stimulant prescription and nonprescription products such as pseudoephedrine, bronchial inhalers containing sympathomimetics (epinephrine or other beta-receptor agonist) or herbal products in the 7 days prior to screening or has a need to use these drugs during the course of the study.
- Use of any SNRIs/SSRIs antidepressants or tricyclic antidepressant up to7 days or 5 half-lives (whichever is longer) prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial.
- Use of MAO Inhibitor drugs up to14 days prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial.
- Has a history of abuse of controlled substances, nasal or otherwise, or has damage to the nasal space, that in the opinion of the investigator might interfere with the ability to absorb RX0041-002.
- Has severely traumatized mucosa or sepsis in the nasal cavity.
Show all 23Show fewer
- Has participated in an investigational study or received an investigational drug within 30 days preceding the randomization.
- Is a pregnant or nursing mother.
- Has a positive pregnancy test at Screening or Day 1.
- Has a history of seizure, with the exception of febrile seizures.
- Has glaucoma, symptomatic cardiovascular disease, or moderate to severe hypertension (defined as an average SBP ≥160 mmHg or an average DBP ≥ 100 mmHg at the dosing visit).
- Has a known personal or family history of hereditary pseudocholinesterase deficiency. Study participants will be screened by asking about personal or family history of anesthetic reaction, anesthetic death, and previous diagnosis of psuedocholinesterase deficiency in a relative or personally. Subjects identified with pseudocholinesterase deficiency are at risk for delayed recovery with certain anesthetics (e.g. succinylcholine and ester-based anesthetics).
- Has a known personal or family history of pheochromocytoma. Study participants will be specifically asked if they have been treated for a pheochromocytoma previously or if they have a family member who has been diagnosed with pheochromocytoma (since 10% of these are familial).
- Has a known personal or family history of adrenal tumor.
- ECG abnormalities judged clinically significant by the investigator.
- Has a positive urine test result for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and oxycodone) at Screening or Day 1
- Hematocrit, WBC, or platelets outside the normal limits and judged clinically significant by the investigator.
- Serum potassium outside normal limits and judged clinically significant by the investigator.
- Serum ALT, AST, and bilirubin exceeding 2X ULN for the lab's reference values.
- Evidence of impaired renal function based upon laboratory tests and investigator opinion.
- Clinical chemistry abnormalities judged clinically significant by the investigator.
- Donation of blood (one pint or greater) within four weeks prior to administration of study medication.
- Not suitable for entry into the study in the opinion of the investigator.
About this study
Official title: Systemic Pharmacokinetics of Acute, Topical, Intranasal Administration of RX0041-002 in Healthy Male and Female Subjects
This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute, topical, intranasal administration to healthy male and female volunteers.
Read the detailed description
This is a Phase I, single dose, single-center, open-label study of the plasma and urinary pharmacokinetics of RX004-002 and its major metabolites in male and female healthy subjects.
- Conditions
- Drug Reaction to Analgesic Nos
- Being tested
- RX0041-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX0041-2Drug
Also called TS
Pharmacokinetic study
| Study group | Role | What they receive |
|---|---|---|
| Single-dose, open label RX0041-2 | Experimental | Active Drug Receives: Drug: RX0041-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Measurement of RX0041
Cmax of RX0041
Measured: 24 Hours
Pharmacokinetic Measurement of RX0041
AUC of RX0041
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Reaction to Analgesic NosStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmaceutical Project Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa L Goodhead, MSc, Study director, Clinical/Regulatory Agent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667106
- Sponsor's protocol ID
- 2015016
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Pharmacokinetics of Acute, Topical, Intranasal Administration of RX0041-002 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02667106
- Acronym / sponsor ID
- 2015016
- Conditions
- Drug Reaction to Analgesic Nos
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pharmaceutical Project Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Jan 2016 (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 Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute, topical, intranasal administration to healthy male and female volunteers.
Detailed description
This is a Phase I, single dose, single-center, open-label study of the plasma and urinary pharmacokinetics of RX004-002 and its major metabolites in male and female healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-dose, open label RX0041-2 | Experimental | Drug: RX0041-2Active Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 but ≤ 80 years of age at the time of dosing.
- BMI ≥ 18 and ≤ 32 at the screening visit.
- Females (if of child-bearing potential and sexually active) and males (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 8 days following administration of study drug. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm, intrauterine device (IUD), condom, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method or withdrawal.
- Willing and able to provide written informed consent and able to understand and comply with protocol requirements.
- During the period of study confinement, subjects will be required to abstain from beverages containing grapefruit juice or caffeine.
Key exclusion criteria (23 listed)
- Has a known allergy to any ester based anesthetics including cocaine HCl, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine Amide based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, mepivicaine, bupivicaine, levobupivicaine, ropivicaine, etidocaine, prilocaine, and articaine.
- The use of amphetamines, methylphenidate or other stimulant prescription and nonprescription products such as pseudoephedrine, bronchial inhalers containing sympathomimetics (epinephrine or other beta-receptor agonist) or herbal products in the 7 days prior to screening or has a need to use these drugs during the course of the study.
- Use of any SNRIs/SSRIs antidepressants or tricyclic antidepressant up to7 days or 5 half-lives (whichever is longer) prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial.
- Use of MAO Inhibitor drugs up to14 days prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial.
- Has a history of abuse of controlled substances, nasal or otherwise, or has damage to the nasal space, that in the opinion of the investigator might interfere with the ability to absorb RX0041-002.
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 |
|---|---|---|
| RX0041-2Also: TSPharmacokinetic study | Drug | Single-dose, open label RX0041-2 |
Primary outcome
Pharmacokinetic Measurement of RX0041
Time frame: 24 Hours
Cmax of RX0041
Pharmacokinetic Measurement of RX0041
Time frame: 24 Hours
AUC of RX0041
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 28 Jan 2016.
- Individual participant dataSharing planned: Undecided
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.
Melissa L Goodhead, MSc study director
Clinical/Regulatory Agent
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RX0041-2 in people with Drug Reaction to Analgesic Nos, run by Pharmaceutical Project Solutions, Inc..
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 23 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 28 Jan 2016. 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?
Pharmacokinetic Measurement of RX0041 (time frame: 24 Hours). The study lists 2 primary outcomes in all. 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 28 Jan 2016.