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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-06-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Migraine Migraine With Aura Migraine Without Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STS101 5.2 mg

STS101 (dihydroergotamine nasal powder), 5.2 mg

Group Type EXPERIMENTAL

Dihydroergotamine

Intervention Type DRUG

Dihydroergotamine intranasal powder

STS101 7.0 mg

STS101 (dihydroergotamine nasal powder), 7.0 mg

Group Type EXPERIMENTAL

Dihydroergotamine

Intervention Type DRUG

Dihydroergotamine intranasal powder

STS101 8.6 mg

STS101 (dihydroergotamine nasal powder), 8.6 mg

Group Type EXPERIMENTAL

Dihydroergotamine

Intervention Type DRUG

Dihydroergotamine intranasal powder

DHE intramuscular injection

Dihydroergotamine mesylate

Group Type ACTIVE_COMPARATOR

Dihydroergotamine

Intervention Type DRUG

Dihydroergotamine intramuscular injection

DHE nasal spray

Dihydroergotamine mesylate

Group Type ACTIVE_COMPARATOR

Dihydroergotamine

Intervention Type DRUG

Dihydroergotamine intranasal spray

Interventions

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Dihydroergotamine

Dihydroergotamine intranasal powder

Intervention Type DRUG

Dihydroergotamine

Dihydroergotamine intramuscular injection

Intervention Type DRUG

Dihydroergotamine

Dihydroergotamine intranasal spray

Intervention Type DRUG

Other Intervention Names

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Dihydroergotamine Mesylate Dihydroergotamine Mesylate Dihydroergotamine Mesylate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes