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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

NCT03874832 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-11-26

No results posted yet for this study

Summary

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

Conditions

  • Migraine With Aura
  • Migraine Without Aura
  • Migraine

Interventions

DRUG

Dihydroergotamine

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Sponsors & Collaborators

  • Satsuma Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey A Levy, MD, PhD · 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
2018-09-11
Primary Completion
2018-11-07
Completion
2018-11-07
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 NCT03874832 on ClinicalTrials.gov