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, Inc.46 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine With Aura Migraine Without Aura Migraine

Interventions

DihydroergotamineDRUG

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quotient Sciences Miami Inc.

Miami, Florida, United States