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

Phase 1

Completed

• Conditions: Migraine Without Aura; Migraine With Aura; Migraine
• Interventions: Drug: Dihydroergotamine

• Registration Number: NCT05337254
• Lead Sponsor: Satsuma Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2021-03-05
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Study First Submitted: 2022-03-29
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
STS101 7.0 mg	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), 7.0 mg
STS101 5.2 mg	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), 5.2 mg
DHE nasal spray	Dihydroergotamine	Dihydroergotamine mesylate
DHE intramuscular injection	Dihydroergotamine	Dihydroergotamine mesylate
STS101 8.6 mg	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), 8.6 mg

Primary Outcome Measures

Name	Time	Method
DHE Relative Bioavailability	Pre-dose through 48 hours Post-Dose	The relative bioavailability of STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of dose-corrected Cmax.
DHE Comparative Bioavailability	Pre-dose through 48 hours Post-Dose	The comparative bioavailability STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of Cmax .

Secondary Outcome Measures

Name	Time	Method
Serious Adverse Events	Pre-dose through 48 hours Post-Dose	To assess the safety profile through examination of serious adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray
Treatment-Related Adverse Events	Pre-dose through 48 hours Post-Dose	To assess the safety profile through examination of treatment-related adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray

Trial Locations

Locations (1)

Quotient Sciences Miami Inc.; 🇺🇸 Miami, Florida, United States