Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis

NCT05887843 | Terminated Phase 1

• 2 other identifiers: SAN-07912023-000362-34
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (6)

• AUCt

  The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method.

  From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

• AUCinf

  The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration.

  From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

• Cmax

  Maximum measured analyte concentration over the sampling period.

  From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

• Tmax

  Time of the maximum measured analyte concentration over the sampling period.

  From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

• Kel

  The apparent first-order elimination rate constant

  From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

• Thalf

  The apparent elimination half-life

  From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

Study Arms (3)

Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride

EXPERIMENTAL

Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride

Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine

EXPERIMENTAL

Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride

Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate

EXPERIMENTAL

Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride

Interventions

Mometasone + Azelastine DRUG

Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate; Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride; Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine

Mometasone Furoate DRUG

Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate; Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride; Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine

Azelastine Hydrochloride DRUG

Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate; Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride; Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
• Willing to use acceptable, effective methods of contraception.
• Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure.

You may not qualify if:

• Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
• Unable to tolerate direct venipuncture.
• Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
• Positive test result for urine drugs of abuse or urine cotinine.
• Presence of nostril or septum piercing.
• Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
• Females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration.
• Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
• Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
• Received any type of live vaccine within 30 days prior to drug administration.
• Use of medication within 30 days prior to drug administration.
• On a special diet within 30 days prior to drug administration.
• Have had a tattoo or body piercing within 30 days prior to drug administration.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigational Site

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate; azelastine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: June 8, 2023
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CA (1)