NCT05337254

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

A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Satsuma Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

Detailed description

36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.

Conditions

• Migraine
• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
DRUG	Dihydroergotamine	Dihydroergotamine intranasal powder
DRUG	Dihydroergotamine	Dihydroergotamine intramuscular injection
DRUG	Dihydroergotamine	Dihydroergotamine intranasal spray

Timeline

• Start date: 2021-03-05
• Primary completion: 2021-06-04
• Completion: 2021-06-04
• First posted: 2022-04-20
• Last updated: 2022-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study