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

Phase 1

Completed

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

• Registration Number: NCT03874832
• Lead Sponsor: Satsuma Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2018-09-11
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-07
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 6.0 mg	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), 6.0 mg
STS101 1.5 mg	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), 1.5 mg
DHE intramuscular injection	Dihydroergotamine	Dihydroergotamine mesylate
STS101 3.0 mg	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), 3.0 mg
DHE nasal spray	Dihydroergotamine	Dihydroergotamine mesylate

Primary Outcome Measures

Name	Time	Method
STS101 Dose Selection - Part 1	Pre-dose through 48 hours post-dose	To select a dose level of STS101 for further evaluation in Part 2
DHE Relative Bioavailability - Part 2	Pre-dose through 48 hours post-dose	To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray

Secondary Outcome Measures

Name	Time	Method
8'OH-DHE Area Under the Curve [AUC] - Part 1	Pre-dose through 48 hours post-dose	To describe the pharmacokinetic profile based on the AUC of 8'hydroxydihydroergotamine (8'OH-DHE) following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101
Serious Adverse Events - Parts 1 & 2	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
DHE Area Under the Curve [AUC] - Part 1	Pre-dose through 48 hours post-dose	To describe the pharmacokinetic profile based on the AUC of dihydroergotamine following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101
Treatment-Related Adverse Events - Parts 1 & 2	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