Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine
Brief summary
Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.
Detailed description
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.
Interventions
Dihydroergotamine intranasal powder
Sponsors
Satsuma Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DHE Relative Bioavailability | Pre-dose through 48 hours Post-Dose | 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. |
| DHE Comparative Bioavailability | Pre-dose through 48 hours Post-Dose | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Pre-dose through 48 hours Post-Dose | 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 |
| Treatment-Related Adverse Events | Pre-dose through 48 hours Post-Dose | 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 |
Countries
United States
Outcome results
None listed