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Completed

NCT Number: NCT05337254

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

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine With Aura Migraine Without Aura Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Miami Inc.

Miami, Florida, 33126, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dihydroergotamine

Drug

Dihydroergotamine intranasal powder

Other names: Dihydroergotamine Mesylate

Primary outcomes

  1. DHE Relative Bioavailability

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

    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.

  2. DHE Comparative Bioavailability

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

    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 .

Secondary outcomes

  1. Serious Adverse Events

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

    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

  2. Treatment-Related Adverse Events

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

    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

Sponsors and collaborators

Lead sponsor

Satsuma Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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