NCT03874832

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

A Randomized, Open-Label, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Satsuma Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Migraine With Aura
• Migraine Without Aura
• Migraine

Interventions

Type	Name	Description
DRUG	Dihydroergotamine	Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Timeline

• Start date: 2018-09-11
• Primary completion: 2018-11-07
• Completion: 2018-11-07
• First posted: 2019-03-14
• Last updated: 2019-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study