A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
NCT ID: NCT03874832
Last Updated: 2019-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2018-09-11
2018-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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STS101 1.5 mg
STS101 (dihydroergotamine nasal powder), 1.5 mg
Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
STS101 3.0 mg
STS101 (dihydroergotamine nasal powder), 3.0 mg
Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
STS101 6.0 mg
STS101 (dihydroergotamine nasal powder), 6.0 mg
Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
DHE intramuscular injection
Dihydroergotamine mesylate
Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
DHE nasal spray
Dihydroergotamine mesylate
Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Interventions
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Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed the informed consent document.
* Subject judged to be healthy by a qualified physician
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Satsuma Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey A Levy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Quotient Sciences Miami Inc.
Locations
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Quotient Sciences Miami Inc.
Miami, Florida, United States
Countries
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References
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Albrecht D, Iwashima M, Dillon D, Harris S, Levy J. A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects. Headache. 2020 Apr;60(4):701-712. doi: 10.1111/head.13737. Epub 2020 Jan 27.
Other Identifiers
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STS101-001
Identifier Type: -
Identifier Source: org_study_id
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