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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.

Tracking Information
First Submitted Date  ICMJE March 7, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE September 11, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine With Aura
  • Migraine Without Aura
  • Migraine
Intervention  ICMJE Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Name: Dihydroergotamine Mesylate
Study Arms  ICMJE
  • Experimental: STS101 1.5 mg
    STS101 (dihydroergotamine nasal powder), 1.5 mg
    Intervention: Drug: Dihydroergotamine
  • Experimental: STS101 3.0 mg
    STS101 (dihydroergotamine nasal powder), 3.0 mg
    Intervention: Drug: Dihydroergotamine
  • Experimental: STS101 6.0 mg
    STS101 (dihydroergotamine nasal powder), 6.0 mg
    Intervention: Drug: Dihydroergotamine
  • Active Comparator: DHE intramuscular injection
    Dihydroergotamine mesylate
    Intervention: Drug: Dihydroergotamine
  • Active Comparator: DHE nasal spray
    Dihydroergotamine mesylate
    Intervention: Drug: Dihydroergotamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 7, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874832
Other Study ID Numbers  ICMJE STS101-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Satsuma Pharmaceuticals, Inc.
Study Sponsor  ICMJE Satsuma Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey A Levy, MD, PhD Quotient Sciences Miami Inc.
PRS Account Satsuma Pharmaceuticals, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP