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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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ClinicalTrials.gov Identifier: NCT03874832
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Satsuma Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Migraine With Aura Migraine Without Aura Migraine Drug: Dihydroergotamine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 11, 2018
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018


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 Name: 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 Name: 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 Name: Dihydroergotamine Mesylate

Active Comparator: DHE intramuscular injection
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Name: Dihydroergotamine Mesylate

Active Comparator: DHE nasal spray
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Name: Dihydroergotamine Mesylate




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874832


Locations
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United States, Florida
Quotient Sciences Miami Inc.
Miami, Florida, United States, 33126
Sponsors and Collaborators
Satsuma Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Jeffrey A Levy, MD, PhD Quotient Sciences Miami Inc.

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Responsible Party: Satsuma Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03874832     History of Changes
Other Study ID Numbers: STS101-001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Satsuma Pharmaceuticals, Inc.:
dihydroergotamine
dihydroergotamine mesylate
migraine

Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dihydroergotamine
Vasoconstrictor Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents