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

NCT05337254 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-04-20

No results posted yet for this study

Summary

Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

Conditions

  • Migraine
  • Migraine With Aura
  • Migraine Without Aura

Interventions

DRUG

Dihydroergotamine

Dihydroergotamine intranasal powder

DRUG

Dihydroergotamine

Dihydroergotamine intramuscular injection

DRUG

Dihydroergotamine

Dihydroergotamine intranasal spray

Sponsors & Collaborators

  • Satsuma Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Levy, MD · Quotient Sciences Miami Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2021-06-04
Completion
2021-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05337254 on ClinicalTrials.gov