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

Primary Purpose

Migraine With Aura, Migraine Without Aura, Migraine

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dihydroergotamine
Sponsored by
Satsuma Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura focused on measuring dihydroergotamine, dihydroergotamine mesylate, migraine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Quotient Sciences Miami Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

STS101 1.5 mg

STS101 3.0 mg

STS101 6.0 mg

DHE intramuscular injection

DHE nasal spray

Arm Description

STS101 (dihydroergotamine nasal powder), 1.5 mg

STS101 (dihydroergotamine nasal powder), 3.0 mg

STS101 (dihydroergotamine nasal powder), 6.0 mg

Dihydroergotamine mesylate

Dihydroergotamine mesylate

Outcomes

Primary Outcome Measures

STS101 Dose Selection - Part 1
To select a dose level of STS101 for further evaluation in Part 2
DHE Relative Bioavailability - Part 2
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

Secondary Outcome Measures

DHE Area Under the Curve [AUC] - Part 1
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
8'OH-DHE Area Under the Curve [AUC] - Part 1
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
Serious Adverse Events - Parts 1 & 2
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
Treatment-Related Adverse Events - Parts 1 & 2
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

Full Information

First Posted
March 7, 2019
Last Updated
November 25, 2019
Sponsor
Satsuma Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03874832
Brief Title
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satsuma Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura, Migraine
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STS101 1.5 mg
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), 1.5 mg
Arm Title
STS101 3.0 mg
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), 3.0 mg
Arm Title
STS101 6.0 mg
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), 6.0 mg
Arm Title
DHE intramuscular injection
Arm Type
Active Comparator
Arm Description
Dihydroergotamine mesylate
Arm Title
DHE nasal spray
Arm Type
Active Comparator
Arm Description
Dihydroergotamine mesylate
Intervention Type
Drug
Intervention Name(s)
Dihydroergotamine
Other Intervention Name(s)
Dihydroergotamine Mesylate
Intervention Description
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Primary Outcome Measure Information:
Title
STS101 Dose Selection - Part 1
Description
To select a dose level of STS101 for further evaluation in Part 2
Time Frame
Pre-dose through 48 hours post-dose
Title
DHE Relative Bioavailability - Part 2
Description
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
Time Frame
Pre-dose through 48 hours post-dose
Secondary Outcome Measure Information:
Title
DHE Area Under the Curve [AUC] - Part 1
Description
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
Time Frame
Pre-dose through 48 hours post-dose
Title
8'OH-DHE Area Under the Curve [AUC] - Part 1
Description
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
Time Frame
Pre-dose through 48 hours post-dose
Title
Serious Adverse Events - Parts 1 & 2
Description
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
Time Frame
Pre-dose through 48 hours post-dose
Title
Treatment-Related Adverse Events - Parts 1 & 2
Description
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
Time Frame
Pre-dose through 48 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Levy, MD, PhD
Organizational Affiliation
Quotient Sciences Miami Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Sciences Miami Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31985049
Citation
Albrecht D, Iwashima M, Dillon D, Harris S, Levy J. A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects. Headache. 2020 Apr;60(4):701-712. doi: 10.1111/head.13737. Epub 2020 Jan 27.
Results Reference
derived

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

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