Clinical trial NCT03874832: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine With Aura
Migraine Without Aura
Migraine
Keywords: dihydroergotamine
dihydroergotamine mesylate
migraine
Lead sponsor: Satsuma Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: STS101 Dose Selection - Part 1
timeFrame: Pre-dose through 48 hours post-dose
measure: DHE Relative Bioavailability - Part 2
timeFrame: Pre-dose through 48 hours post-dose
Secondary outcomes:
measure: DHE Area Under the Curve [AUC] - Part 1
timeFrame: Pre-dose through 48 hours post-dose
measure: 8'OH-DHE Area Under the Curve [AUC] - Part 1
timeFrame: Pre-dose through 48 hours post-dose
measure: Serious Adverse Events - Parts 1 & 2
timeFrame: Pre-dose through 48 hours post-dose
measure: Treatment-Related Adverse Events - Parts 1 & 2
timeFrame: Pre-dose through 48 hours post-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami Inc.
state: Florida
Study officials:
affiliation: Quotient Sciences Miami Inc.
name: Jeffrey A Levy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.