Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

NCT06074016 | Completed Phase 1 Results

• 1 other identifier: IMIMFCTL/ZOL_1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Effects of Zolmitriptan on Heart Rate (HR).

  To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.

  Up to 24 hours.

• Effects of Zolmitriptan on Systolic Blood Pressure (SBP).

  To assess the effects of Zolmitriptan on SBP; only results at 24 hours will be reported.

  Up to 24 hours.

• Effects of Zolmitriptan Diastolic Blood Pressure (DBP)

  To assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported.

  Up to 24 hours

• AUC(0-24h)

  Area under the curve from 0 time to the last measurable concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.

  up to 24 hours

• Tmax

  Time of maximum observed concentration (of oral and intranasal zolmitriptan), 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 oral and intranasal zolmitriptan), 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.

Study Arms (2)

Zolmitriptan intranasal.

EXPERIMENTAL

Drug: Zolmitriptan intranasal.

Zolmitriptan oral.

EXPERIMENTAL

Drug: Zolmitriptan oral.

Interventions

Zolmitriptan intranasal. DRUG

Zolmitriptan nasal spray is supplied in a single-use, ready-to-use spray unit. It is administered in one nostril. The full protocol will explain how to use it. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.

Zolmitriptan intranasal.

Zolmitriptan oral. DRUG

Zolmitriptan 5 mg orally disintegrating tablet is to be taken without liquids. For oral administration, each tablet will be placed in the top of the tongue without any liquid and will disperse in a matter of seconds, then be swallowed with saliva. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.

Zolmitriptan oral.

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 by physical examination, vital signs, ECG, and safety laboratory parameters and results must be within normal ranges or considered not clinically relevant by the investigator.
• Age ≥ 18 years and ≤ 55 years.
• Body mass index (BMI) ≥ 18 and ≤ 30.
• Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine-containing items when outside the Clinical Research Unit (CRU)
• Able to read Spanish and adhere to study requirements.
• Informed consent signed before any procedure required by the study.

You may not qualify if:

• Smoking.
• History or clinically relevant diseases.
• Be under administrative or legal supervision.
• Pregnancy and breastfeeding.
• Positive blood or urine drug of abuse test or breathalyzer prior to study drug administration.
• Any history, disease, disorder, condition, anomaly or clinical finding that is relevant in the judgment of the investigator that may interfere with the study.
• Known hypersensitivity to any drug or excipient of the drug.
• Use of medications, inhibitors, any prescription or over-the-counter products, including herbs, homeopathy, vitamins, minerals, and nutritional supplements, before or during the study, that may interfere with the conduct and results of the study.
• Donation or transfusion of blood or plasma before, during or after study drug administration.
• History of inadequate venous access and/or experience of difficulty donating blood.
• Not being able/unwilling to accept restrictions regarding diet, physical exercise and consumption of alcohol and/or articles containing xanthine when outside the CRU.
• Subject included in a clinical study in the 3 months prior to the study drug administration.

Sponsors & Collaborators

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

Study Sites (1)

IMIM (Hospital del Mar Medical Research Institute)

Barcelona, 08003, Spain

Location

MeSH Terms

Interventions

zolmitriptan

Results Point of Contact

• Title: Rafael de la Torre Fornell/Ana M aldea Perona
• Organization: Consorci PSMAR

rtorre@researchmar.net

(+34) 93 3160484

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 10, 2023
• Study Start: July 12, 2023
• Primary Completion: September 6, 2023
• Study Completion: September 29, 2023
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2023-06

Locations

ES (1)