Status:
COMPLETED
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Lead Sponsor:
Satsuma Pharmaceuticals, Inc.
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 i...
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 :
September 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03874832
Start Date
September 11 2018
End Date
November 7 2018
Last Update
November 26 2019
Active Locations (1)
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1
Quotient Sciences Miami Inc.
Miami, Florida, United States, 33126