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

April 13, 2022 updated by: Satsuma Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Quotient Sciences Miami Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STS101 5.2 mg
STS101 (dihydroergotamine nasal powder), 5.2 mg
Drug: Dihydroergotamine
Dihydroergotamine intranasal powder
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intramuscular injection
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal spray
Other Names:
  • Dihydroergotamine Mesylate
Experimental: STS101 7.0 mg
STS101 (dihydroergotamine nasal powder), 7.0 mg
Drug: Dihydroergotamine
Dihydroergotamine intranasal powder
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intramuscular injection
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal spray
Other Names:
  • Dihydroergotamine Mesylate
Experimental: STS101 8.6 mg
STS101 (dihydroergotamine nasal powder), 8.6 mg
Drug: Dihydroergotamine
Dihydroergotamine intranasal powder
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intramuscular injection
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal spray
Other Names:
  • Dihydroergotamine Mesylate
Active Comparator: DHE intramuscular injection
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal powder
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intramuscular injection
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal spray
Other Names:
  • Dihydroergotamine Mesylate
Active Comparator: DHE nasal spray
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal powder
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intramuscular injection
Other Names:
  • Dihydroergotamine Mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal spray
Other Names:
  • Dihydroergotamine Mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-dose through 48 hours Post-Dose
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 .
Pre-dose through 48 hours Post-Dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-dose through 48 hours Post-Dose
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
Pre-dose through 48 hours Post-Dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satsuma Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Jeffrey Levy, MD, Quotient Sciences Miami Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

June 4, 2021

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STS101-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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