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

• Status: Completed
• Trial end date: 2018-11-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Satsuma Pharmaceuticals, Inc.
• Treatments: Dihydroergotamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.