A Randomized, Open-Label, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Dihydroergotamine
- Conditions
- Migraine With Aura
- Sponsor
- Satsuma Pharmaceuticals, Inc.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- STS101 Dose Selection - Part 1
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
STS101 1.5 mg
STS101 (dihydroergotamine nasal powder), 1.5 mg
Intervention: Dihydroergotamine
STS101 3.0 mg
STS101 (dihydroergotamine nasal powder), 3.0 mg
Intervention: Dihydroergotamine
STS101 6.0 mg
STS101 (dihydroergotamine nasal powder), 6.0 mg
Intervention: Dihydroergotamine
DHE intramuscular injection
Dihydroergotamine mesylate
Intervention: Dihydroergotamine
DHE nasal spray
Dihydroergotamine mesylate
Intervention: Dihydroergotamine
Outcomes
Primary Outcomes
STS101 Dose Selection - Part 1
Time Frame: 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
Time Frame: 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 Outcomes
- 8'OH-DHE Area Under the Curve [AUC] - Part 1(Pre-dose through 48 hours post-dose)
- Serious Adverse Events - Parts 1 & 2(Pre-dose through 48 hours post-dose)
- DHE Area Under the Curve [AUC] - Part 1(Pre-dose through 48 hours post-dose)
- Treatment-Related Adverse Events - Parts 1 & 2(Pre-dose through 48 hours post-dose)