A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling

NCT07223450 | Completed Phase 1 Results

• 1 other identifier: 2024-515461-34-00
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers; Physiologically Based Pharmacokinetic

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 24 hours

• Tmax

  Time of maximum observed concentration (of intranasal and oral oxycodone), calculated from individual plasma PK concentrations.

  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

  Blood samples were taken pre-dose and up to 24 hours after start of each Dose

Secondary Outcomes (1)

• Adverse Effects (AE)

  Up to 24 hours

Other Outcomes (1)

• Pupil Diameter

  up to 24 hours

Study Arms (2)

Oral oxycodone

ACTIVE COMPARATOR

Drug: oxycodone

intranasal oxycodone

EXPERIMENTAL

Drug: Oxycodone IN

Interventions

Oxycodone IN DRUG

0.1 mg/kg intravenously oxycodone solution administered intranasally

intranasal oxycodone

oxycodone DRUG

oral solution 0.1 mg/kg

Oral oxycodone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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,
• 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).

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Food and Drug Administration (FDA): collaborator
• University of Manchester: collaborator

Study Sites (1)

Hospital del Mar Research Institute

Barcelona, Spain

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Ana Mª Aldea Perona
• Organization: Hospital del Mar Research Institute

aaldea@researchmar.net

(+34) 93 316 04 90

Study Officials

• Rafael De la Torre, PhD

  Hospital del Mar Research Institute Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: October 31, 2025
• Study Start: June 12, 2025
• Primary Completion: October 7, 2025
• Study Completion: October 7, 2025
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2025-06

Locations

ES (1)