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

November 25, 2019 updated by: Satsuma Pharmaceuticals, Inc.

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

Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Actual)

46

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

Yes

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: STS101 1.5 mg
STS101 (dihydroergotamine nasal powder), 1.5 mg
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Names:
  • Dihydroergotamine Mesylate
EXPERIMENTAL: STS101 3.0 mg
STS101 (dihydroergotamine nasal powder), 3.0 mg
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Names:
  • Dihydroergotamine Mesylate
EXPERIMENTAL: STS101 6.0 mg
STS101 (dihydroergotamine nasal powder), 6.0 mg
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Names:
  • Dihydroergotamine Mesylate
ACTIVE_COMPARATOR: DHE intramuscular injection
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Names:
  • Dihydroergotamine Mesylate
ACTIVE_COMPARATOR: DHE nasal spray
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Names:
  • Dihydroergotamine Mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STS101 Dose Selection - Part 1
Time Frame: Pre-dose through 48 hours post-dose
To select a dose level of STS101 for further evaluation in Part 2
Pre-dose through 48 hours post-dose
DHE Relative Bioavailability - Part 2
Time Frame: Pre-dose through 48 hours post-dose
To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray
Pre-dose through 48 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DHE Area Under the Curve [AUC] - Part 1
Time Frame: Pre-dose through 48 hours post-dose
To describe the pharmacokinetic profile based on the AUC of dihydroergotamine following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101
Pre-dose through 48 hours post-dose
8'OH-DHE Area Under the Curve [AUC] - Part 1
Time Frame: Pre-dose through 48 hours post-dose
To describe the pharmacokinetic profile based on the AUC of 8'hydroxydihydroergotamine (8'OH-DHE) following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101
Pre-dose through 48 hours post-dose
Serious Adverse Events - Parts 1 & 2
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 - Parts 1 & 2
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 A Levy, MD, PhD, Quotient Sciences Miami Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 11, 2018

Primary Completion (ACTUAL)

November 7, 2018

Study Completion (ACTUAL)

November 7, 2018

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (ACTUAL)

March 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STS101-001

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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