A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Study Overview
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Brief Summary
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Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

Detailed Description
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36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.

Official Title
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A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

Conditions
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Migraine, Migraine With Aura, Migraine Without Aura

Intervention / Treatment
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* Drug: Dihydroergotamine
* Drug: Dihydroergotamine
* Drug: Dihydroergotamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 50 years of age at the time of enrollment. Signed the informed consent document. Subject judged to be healthy by a qualified physician Exclusion Criteria: Abnormal physical findings of clinical significance at the screening examination Significant abnormal laboratory values at the Screening Visit. Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STS101 5.2 mg<br>STS101 (dihydroergotamine nasal powder), 5.2 mg | Drug: Dihydroergotamine<br>* Dihydroergotamine intranasal powder<br>* Other names: Dihydroergotamine Mesylate;|
| Experimental: STS101 7.0 mg<br>STS101 (dihydroergotamine nasal powder), 7.0 mg | Drug: Dihydroergotamine<br>* Dihydroergotamine intranasal powder<br>* Other names: Dihydroergotamine Mesylate;|
| Experimental: STS101 8.6 mg<br>STS101 (dihydroergotamine nasal powder), 8.6 mg | Drug: Dihydroergotamine<br>* Dihydroergotamine intranasal powder<br>* Other names: Dihydroergotamine Mesylate;|
| Active Comparator: DHE intramuscular injection<br>Dihydroergotamine mesylate | Drug: Dihydroergotamine<br>* Dihydroergotamine intramuscular injection<br>* Other names: Dihydroergotamine Mesylate;|
| Active Comparator: DHE nasal spray<br>Dihydroergotamine mesylate | Drug: Dihydroergotamine<br>* Dihydroergotamine intranasal spray<br>* Other names: Dihydroergotamine Mesylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DHE Relative Bioavailability | The relative bioavailability of STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of dose-corrected Cmax. | Pre-dose through 48 hours Post-Dose | 
| DHE Comparative Bioavailability | The comparative bioavailability STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of Cmax . | Pre-dose through 48 hours Post-Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | To assess the safety profile through examination of serious adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray | Pre-dose through 48 hours Post-Dose | 
| Treatment-Related Adverse Events | To assess the safety profile through examination of treatment-related adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray | Pre-dose through 48 hours Post-Dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dihydroergotamine, dihydroergotamine mesylate, migraine