Back to resultsA Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Primary Purpose
Migraine, Migraine With Aura, Migraine Without Aura
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dihydroergotamine
Dihydroergotamine
Dihydroergotamine
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring dihydroergotamine, dihydroergotamine mesylate, migraine
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.
Sites / Locations
- Quotient Sciences Miami Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
STS101 5.2 mg
STS101 7.0 mg
STS101 8.6 mg
DHE intramuscular injection
DHE nasal spray
Arm Description
STS101 (dihydroergotamine nasal powder), 5.2 mg
STS101 (dihydroergotamine nasal powder), 7.0 mg
STS101 (dihydroergotamine nasal powder), 8.6 mg
Dihydroergotamine mesylate
Dihydroergotamine mesylate
Outcomes
Primary Outcome Measures
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.
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 .
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05337254
First Posted
March 29, 2022
Last Updated
April 13, 2022
Sponsor
Satsuma Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05337254
Brief Title
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satsuma Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Migraine With Aura, Migraine Without Aura
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STS101 5.2 mg
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), 5.2 mg
Arm Title
STS101 7.0 mg
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), 7.0 mg
Arm Title
STS101 8.6 mg
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), 8.6 mg
Arm Title
DHE intramuscular injection
Arm Type
Active Comparator
Arm Description
Dihydroergotamine mesylate
Arm Title
DHE nasal spray
Arm Type
Active Comparator
Arm Description
Dihydroergotamine mesylate
Intervention Type
Drug
Intervention Name(s)
Dihydroergotamine
Other Intervention Name(s)
Dihydroergotamine Mesylate
Intervention Description
Dihydroergotamine intranasal powder
Intervention Type
Drug
Intervention Name(s)
Dihydroergotamine
Other Intervention Name(s)
Dihydroergotamine Mesylate
Intervention Description
Dihydroergotamine intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Dihydroergotamine
Other Intervention Name(s)
Dihydroergotamine Mesylate
Intervention Description
Dihydroergotamine intranasal spray
Primary Outcome Measure Information:
Title
DHE Relative Bioavailability
Description
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.
Time Frame
Pre-dose through 48 hours Post-Dose
Title
DHE Comparative Bioavailability
Description
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 .
Time Frame
Pre-dose through 48 hours Post-Dose
Secondary Outcome Measure Information:
Title
Serious Adverse Events
Description
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
Time Frame
Pre-dose through 48 hours Post-Dose
Title
Treatment-Related Adverse Events
Description
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
Time Frame
Pre-dose through 48 hours Post-Dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Levy, MD
Organizational Affiliation
Quotient Sciences Miami Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Sciences Miami Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
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