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Clinical Trial Summary

Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03874832
Study type Interventional
Source Satsuma Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date September 11, 2018
Completion date November 7, 2018

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