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

Sponsor

Satsuma Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05337254

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Migraine Migraine With Aura Migraine Without Aura	Drug: Dihydroergotamine Drug: Dihydroergotamine Drug: Dihydroergotamine	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 5, 2021

Actual Primary Completion Date :

Jun 4, 2021

Actual Study Completion Date :

Jun 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STS101 5.2 mg STS101 (dihydroergotamine nasal powder), 5.2 mg	Drug: Dihydroergotamine Dihydroergotamine intranasal powder Other Names: Dihydroergotamine Mesylate
Experimental: STS101 7.0 mg STS101 (dihydroergotamine nasal powder), 7.0 mg	Drug: Dihydroergotamine Dihydroergotamine intranasal powder Other Names: Dihydroergotamine Mesylate
Experimental: STS101 8.6 mg STS101 (dihydroergotamine nasal powder), 8.6 mg	Drug: Dihydroergotamine Dihydroergotamine intranasal powder Other Names: Dihydroergotamine Mesylate
Active Comparator: DHE intramuscular injection Dihydroergotamine mesylate	Drug: Dihydroergotamine Dihydroergotamine intramuscular injection Other Names: Dihydroergotamine Mesylate
Active Comparator: DHE nasal spray Dihydroergotamine mesylate	Drug: Dihydroergotamine Dihydroergotamine intranasal spray Other Names: Dihydroergotamine Mesylate

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.