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Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.
Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STS101 1.5 mg | Experimental | STS101 (dihydroergotamine nasal powder), 1.5 mg |
|
| STS101 3.0 mg | Experimental | STS101 (dihydroergotamine nasal powder), 3.0 mg |
|
| STS101 6.0 mg | Experimental | STS101 (dihydroergotamine nasal powder), 6.0 mg |
|
| DHE intramuscular injection | Active Comparator | Dihydroergotamine mesylate |
|
| DHE nasal spray | Active Comparator | Dihydroergotamine mesylate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroergotamine | Drug | Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| STS101 Dose Selection - Part 1 | To select a dose level of STS101 for further evaluation in Part 2 | Pre-dose through 48 hours post-dose |
| DHE Relative Bioavailability - Part 2 | To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray | Pre-dose through 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| DHE Area Under the Curve [AUC] - Part 1 | To describe the pharmacokinetic profile based on the AUC of dihydroergotamine following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101 | Pre-dose through 48 hours post-dose |
| 8'OH-DHE Area Under the Curve [AUC] - Part 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A Levy, MD, PhD | Quotient Sciences Miami Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami Inc. | Miami | Florida | 33126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31985049 | Derived | Albrecht D, Iwashima M, Dillon D, Harris S, Levy J. A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects. Headache. 2020 Apr;60(4):701-712. doi: 10.1111/head.13737. Epub 2020 Jan 27. |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004087 | Dihydroergotamine |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
To describe the pharmacokinetic profile based on the AUC of 8'hydroxydihydroergotamine (8'OH-DHE) following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101 |
| Pre-dose through 48 hours post-dose |
| Serious Adverse Events - Parts 1 & 2 | 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 - Parts 1 & 2 | 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 |
| D009422 | Nervous System Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |