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

Satsuma Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Migraine With Aura; Migraine Without Aura; Migraine

Treatments: Drug: Dihydroergotamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05337254

STS101-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 5 patient groups

STS101 5.2 mg

Experimental group

Description:

STS101 (dihydroergotamine nasal powder), 5.2 mg

Treatment:

Drug: Dihydroergotamine

Drug: Dihydroergotamine

Drug: Dihydroergotamine

STS101 7.0 mg

Experimental group

Description:

STS101 (dihydroergotamine nasal powder), 7.0 mg

Treatment:

Drug: Dihydroergotamine

Drug: Dihydroergotamine

Drug: Dihydroergotamine

STS101 8.6 mg

Experimental group

Description:

STS101 (dihydroergotamine nasal powder), 8.6 mg

Treatment:

Drug: Dihydroergotamine

Drug: Dihydroergotamine

Drug: Dihydroergotamine

DHE intramuscular injection

Active Comparator group

Description:

Dihydroergotamine mesylate

Treatment:

Drug: Dihydroergotamine

Drug: Dihydroergotamine

Drug: Dihydroergotamine

DHE nasal spray

Active Comparator group

Description:

Dihydroergotamine mesylate

Treatment:

Drug: Dihydroergotamine

Drug: Dihydroergotamine

Drug: Dihydroergotamine