Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Sponsor

Parc de Salut Mar (Other)

Overall Status

Completed

CT.gov ID

NCT06074016

Collaborator

Food and Drug Administration (FDA) (U.S. Fed)

Enrollment

Location

Arms

2.6

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Zolmitriptan intranasal. Drug: Zolmitriptan oral.	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers

Actual Study Start Date :

Jul 12, 2023

Actual Primary Completion Date :

Sep 6, 2023

Actual Study Completion Date :

Sep 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zolmitriptan intranasal.	Drug: Zolmitriptan intranasal. 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.
Experimental: Zolmitriptan oral.	Drug: Zolmitriptan oral. 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.

Arm

Intervention/Treatment

Experimental: Zolmitriptan intranasal.

Drug: Zolmitriptan intranasal.

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.

Experimental: Zolmitriptan oral.

Drug: Zolmitriptan oral.

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.

Outcome Measures

Primary Outcome Measures

Effects of zolmitriptan on heart rate (HR). [Up to 24 hours.]
Effects of zolmitriptan on systolic and diastolic blood pressure (BP). [Up to 24 hours.]

Secondary Outcome Measures

Concentration of zolmitriptan on vasoactive intestinal polypeptide (VIP) in captures Day 1. [Up to 24 hours.]

Other Outcome Measures

Adverse effects. [Up to 24 hours.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IMIM (Hospital del Mar Medical Research Institute)	Barcelona		Spain	08003

Sponsors and Collaborators

Parc de Salut Mar
Food and Drug Administration (FDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Parc de Salut Mar

ClinicalTrials.gov Identifier:

NCT06074016

Other Study ID Numbers:

IMIMFCTL/ZOL_1

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Oxazolidinones

Zolmitriptan

Study Results

No Results Posted as of Oct 10, 2023