Status:
COMPLETED
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Lead Sponsor:
Satsuma Pharmaceuticals, Inc.
Conditions:
Migraine
Migraine With Aura
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05337254
Start Date
March 5 2021
End Date
June 4 2021
Last Update
April 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Sciences Miami Inc.
Miami, Florida, United States, 33126