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

Migraine Clinical Trial

Official title:

A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337254
• Other study ID #: STS101-006
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2021
• Est. completion date: June 4, 2021

Study information

• Verified date: April 2022
• Source: Satsuma Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Intervention

Drug:
• Dihydroergotamine
Dihydroergotamine intranasal powder
• Dihydroergotamine
Dihydroergotamine intramuscular injection
• Dihydroergotamine
Dihydroergotamine intranasal spray

Locations

Country	Name	City	State
United States	Quotient Sciences Miami Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Satsuma Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DHE Relative Bioavailability	The relative bioavailability of STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of dose-corrected Cmax.	Pre-dose through 48 hours Post-Dose
Primary	DHE Comparative Bioavailability	The comparative bioavailability STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of Cmax .	Pre-dose through 48 hours Post-Dose
Secondary	Serious Adverse Events	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	Pre-dose through 48 hours Post-Dose
Secondary	Treatment-Related Adverse Events	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	Pre-dose through 48 hours Post-Dose