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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 7, 2018

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.

Interventions

  • Drug: Dihydroergotamine
    • Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Arms, Groups and Cohorts

  • Experimental: STS101 1.5 mg
    • STS101 (dihydroergotamine nasal powder), 1.5 mg
  • Experimental: STS101 3.0 mg
    • STS101 (dihydroergotamine nasal powder), 3.0 mg
  • Experimental: STS101 6.0 mg
    • STS101 (dihydroergotamine nasal powder), 6.0 mg
  • Active Comparator: DHE intramuscular injection
    • Dihydroergotamine mesylate
  • Active Comparator: DHE nasal spray
    • Dihydroergotamine mesylate

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Satsuma Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey A Levy, MD, PhD, Principal Investigator, Quotient Sciences Miami Inc.

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