Physiologically Based PharmacokineticPhase 1NCT07223450
A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling
A Phase 1 study testing Oxycodone IN and oxycodone in people with Physiologically Based Pharmacokinetic and Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This is a single-dose, 2-period, 2-sequence, fasting, open label, crossover randomized design, comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of intranasal and oral oxycodone solutions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiologically Based Pharmacokinetic, Healthy Volunteers
- What is being tested?
- Oxycodone IN and oxycodone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2025to 7 Oct 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 male or female volunteers according to physical examination, vital signs (blood pressure, heart rate and body temperature), ECG and safety laboratory parameters and results should be within normal ranges or considered as non-clinically relevant by the investigator.
- Age ≥ 18 and ≤ 55 years.
- Body weight up to 90 kg
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able/willing to be compliant with the study restrictions
- Able to read Spanish and adhere to study requirements.
- Signed informed consent prior to any study-mandated procedure.
- Prior therapeutic or recreational experience with opioids (i.e., tramadol, oxycodone, or buprenorphine)
Who cannot join
- Life-time (current and/or history of) substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Use of any illegal drug within 30 days of screening and throughout participation in the study
- History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
- No acute, chronic, or allergic rhinitis
- Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
- History of severe bronchial asthma or chronic obstructive pulmonary disease,
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- Any anatomical abnormality or pathological condition of the nasal cavity based on medical history.
- History of hypothyroidism.
- Subjects with a clinically relevant disease or condition that in the judgment of the investigator might interfere with the safety or subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
- Current mental diseases that require prescription drugs.
- Any ophthalmologic condition that could interfere with pupillometry
- Being under any administrative or legal supervision.
- Pregnancy and breastfeeding
- Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
- Current and/or history of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the Dual Diagnosis Screening Interview (DDSI).
- CYP2D6 poor or ultrarapid metabolizers.
- Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters.
- Positive hepatitis or HIV tests (Ag VHB, IgG VHC, Ac VIH).
- Known hypersensitivity to any drug or drug excipients.
- Use of drugs known to induce or inhibit hepatic drug metabolism (check drugs in Appendix 6) within one month prior to study administration or during the study and use of citrus juice during the study.
- Use of sedative medicines such as benzodiazepines or related drugs in the last 3 months.
- Any prescription or over-the-counter (OTC) product, not including oral contraceptives but including analgesics (paracetamol), aspirin, herbal, homeopathic, vitamins, minerals and nutritional supplements within one week prior to study drug administration.
- Intake of foods or beverages containing xanthine (more than 5 cups of coffee, tea or 5 bottles/cans cola drinks) per day.
- Donation of blood or plasma within two months prior to study drug administration
- Transfusion of blood or plasma for medical/surgical reasons in the past 120 days.
- Current or history of inadequate venous access and/or experience of difficulty donating blood.
- Subject included in a clinical trial within 3 months prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiologically Based Pharmacokinetic Modelling of Oral and Intranasal Formulations of Oxycodone in Healthy Volunteers
This is a single-dose, 2-period, 2-sequence, fasting, open label, crossover randomized design, comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of intranasal and oral oxycodone solutions. The aim will be to characterize the PK and PD of two formulations of oxycodone (intranasal and oral) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. A total of 8 healthy male/female subjects will be randomly assigned to one of two sequences in the crossover study. All subjects will receive the same dosage of oxycodone intranasal or oral and the sequence will be determined following randomization.
- Being tested
- Oxycodone IN, oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone INDrug
0.1 mg/kg intravenously oxycodone solution administered intranasally
oxycodoneDrug
oral solution 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Oral oxycodone | Active comparator | Not described Receives: Drug: oxycodone |
| intranasal oxycodone | Experimental | Not described Receives: Drug: Oxycodone IN |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-24h)
Area under the curve from 0 time to the last measurable concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Measured: up to 24 hours
Tmax
Time of maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Measured: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Cmax
The mean maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations
Measured: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Secondary outcomes (1)
Adverse Effects (AE)
AE was performed including number and percentage.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start12 Jun 2025
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physiologically Based PharmacokineticStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), University of Manchester
- Responsible party
- Sponsor
- Investigators
- Rafael De la Torre, PhD, Principal investigator, Hospital del Mar Research Institute Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223450
- Sponsor's protocol ID
- 2024-515461-34-00
- Other IDs
- 2024-515461-34-00
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologically Based Pharmacokinetic Modelling of Oral and Intranasal Formulations of Oxycodone in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07223450
- Acronym / sponsor ID
- 2024-515461-34-00
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), University of Manchester
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 31 Oct 2025 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-dose, 2-period, 2-sequence, fasting, open label, crossover randomized design, comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of intranasal and oral oxycodone solutions. The aim will be to characterize the PK and PD of two formulations of oxycodone (intranasal and oral) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. A total of 8 healthy male/female subjects will be randomly assigned to one of two sequences in the crossover study. All subjects will receive the same dosage of oxycodone intranasal or oral and the sequence will be determined following randomization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral oxycodone | Active comparator | Drug: oxycodone |
| intranasal oxycodone | Experimental | Drug: Oxycodone IN |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female volunteers according to physical examination, vital signs (blood pressure, heart rate and body temperature), ECG and safety laboratory parameters and results should be within normal ranges or considered as non-clinically relevant by the investigator.
- Age ≥ 18 and ≤ 55 years.
- Body weight up to 90 kg
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able/willing to be compliant with the study restrictions
Key exclusion criteria (27 listed)
- Life-time (current and/or history of) substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Use of any illegal drug within 30 days of screening and throughout participation in the study
- History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
- No acute, chronic, or allergic rhinitis
- Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
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 |
|---|---|---|
| Oxycodone IN0.1 mg/kg intravenously oxycodone solution administered intranasally | Drug | intranasal oxycodone |
| oxycodoneoral solution 0.1 mg/kg | Drug | Oral oxycodone |
Primary outcome
AUC(0-24h)
Time frame: up to 24 hours
Area under the curve from 0 time to the last measurable concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Tmax
Time frame: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Time of maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.
Cmax
Time frame: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
The mean maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations
1 secondary outcome
Adverse Effects (AE)
Time frame: Up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rafael De la Torre, PhD principal investigator
Hospital del Mar Research Institute Barcelona
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 Oxycodone IN and oxycodone in people with Physiologically Based Pharmacokinetic and Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
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 27 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 6 May 2026. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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(0-24h) (time frame: up to 24 hours). The study lists 3 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 6 May 2026.