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

S

Satsuma Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Migraine With Aura
Migraine Without Aura
Migraine

Treatments

Drug: Dihydroergotamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05337254
STS101-006

Details and patient eligibility

About

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

Full description

36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.

Enrollment

36 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 5 patient groups

STS101 5.2 mg
Experimental group
Description:
STS101 (dihydroergotamine nasal powder), 5.2 mg
Treatment:
Drug: Dihydroergotamine
Drug: Dihydroergotamine
Drug: Dihydroergotamine
STS101 7.0 mg
Experimental group
Description:
STS101 (dihydroergotamine nasal powder), 7.0 mg
Treatment:
Drug: Dihydroergotamine
Drug: Dihydroergotamine
Drug: Dihydroergotamine
STS101 8.6 mg
Experimental group
Description:
STS101 (dihydroergotamine nasal powder), 8.6 mg
Treatment:
Drug: Dihydroergotamine
Drug: Dihydroergotamine
Drug: Dihydroergotamine
DHE intramuscular injection
Active Comparator group
Description:
Dihydroergotamine mesylate
Treatment:
Drug: Dihydroergotamine
Drug: Dihydroergotamine
Drug: Dihydroergotamine
DHE nasal spray
Active Comparator group
Description:
Dihydroergotamine mesylate
Treatment:
Drug: Dihydroergotamine
Drug: Dihydroergotamine
Drug: Dihydroergotamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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