Trial | NCT03874832  Report issue

Title

A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
A Randomized, Open-Label, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    46
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 Started
Sep 11
2018
Primary Completion
Nov 07
2018
Study Completion
Nov 07
2018
Last Update
Nov 26
2019

Drug Dihydroergotamine

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

  • Other names: Dihydroergotamine Mesylate

STS101 1.5 mg Experimental

STS101 (dihydroergotamine nasal powder), 1.5 mg

STS101 3.0 mg Experimental

STS101 (dihydroergotamine nasal powder), 3.0 mg

STS101 6.0 mg Experimental

STS101 (dihydroergotamine nasal powder), 6.0 mg

DHE intramuscular injection Active Comparator

Dihydroergotamine mesylate

DHE nasal spray Active Comparator

Dihydroergotamine mesylate

Criteria 

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.
No Results Posted