A Phase I Study to Study 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

NCT03874832

STS101-001

Details and patient eligibility

About

Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.

Full 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.

Enrollment: 46 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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46 participants in 5 patient groups

STS101 1.5 mg

Experimental group

Description:

STS101 (dihydroergotamine nasal powder), 1.5 mg

Treatment:

Drug: Dihydroergotamine

STS101 3.0 mg

Experimental group

Description:

STS101 (dihydroergotamine nasal powder), 3.0 mg

Treatment:

Drug: Dihydroergotamine

STS101 6.0 mg

Experimental group

Description:

STS101 (dihydroergotamine nasal powder), 6.0 mg

Treatment:

Drug: Dihydroergotamine

DHE intramuscular injection

Active Comparator group

Description:

Dihydroergotamine mesylate

Treatment:

Drug: Dihydroergotamine

DHE nasal spray

Active Comparator group

Description:

Dihydroergotamine mesylate

Treatment:

Drug: Dihydroergotamine