Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine
Brief summary
Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.
Detailed description
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.
Interventions
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
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 |
|---|---|---|
| STS101 Dose Selection - Part 1 | Pre-dose through 48 hours post-dose | To select a dose level of STS101 for further evaluation in Part 2 |
| DHE Relative Bioavailability - Part 2 | Pre-dose through 48 hours post-dose | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DHE Area Under the Curve [AUC] - Part 1 | Pre-dose through 48 hours post-dose | 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 |
| 8'OH-DHE Area Under the Curve [AUC] - Part 1 | Pre-dose through 48 hours post-dose | 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 |
| Serious Adverse Events - Parts 1 & 2 | 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 - Parts 1 & 2 | 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