A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Completed · Phase 1

Conditions studied: Migraine With Aura, Migraine Without Aura, Migraine

In brief

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

Key facts

Study ID

NCT03874832

Run by

Satsuma Pharmaceuticals, Inc.

People needed

46

Starts

2018-09-11

Expected to finish

2018-11-07

Last updated by the study team

2019-11-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Quotient Sciences Miami Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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