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

Satsuma Pharmaceuticals, Inc.36 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine Migraine With Aura Migraine Without Aura

Interventions

DihydroergotamineDRUG

Dihydroergotamine intranasal powder

DihydroergotamineDRUG

Dihydroergotamine intramuscular injection

DihydroergotamineDRUG

Dihydroergotamine intranasal spray

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

Outcomes

Primary Outcomes

DHE Relative Bioavailability

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.

Time frame: Pre-dose through 48 hours Post-Dose

DHE Comparative Bioavailability

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 .

Time frame: Pre-dose through 48 hours Post-Dose

Secondary Outcomes

Serious Adverse Events

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

Time frame: Pre-dose through 48 hours Post-Dose

Treatment-Related Adverse Events

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

Time frame: Pre-dose through 48 hours Post-Dose

Data from ClinicalTrials.gov

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